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Advanced Instruments LLC.
Posted: 12/14/17

Job Title: 

Director, Quality Assurance and Regulatory Affairs

Posting Date:

11/30/17

Work Location: 

Norwood, MA

Department: 

Quality

Reports to: 

VP, Chief Operating Officer

FLSA Status: 

Exempt

Summary:

The Director of QA/RA provides leadership across all departments to ensure quality objectives are met while maintaining global regulatory compliance.  Works directly with senior management to establish short and long term quality objectives while driving a culture of quality throughout the organization.  Direct areas of responsibility include; quality assurance, quality control, supplier quality, document control, quality training and regulatory compliance.

 

Experience Requirements:

  1. Extensive knowledge of ISO 13485, QSR and CE marking.
  2. Ten plus years of regulatory compliance/quality systems/regulatory submissions experience in Class 1 and Class II medical devices required.
  3. Experience with in vitro diagnostics (IVD) is preferred, other applicable experience is a plus.
  4. Five to seven years’ experience as a Sr. Manager or Director.
  5. Demonstratedeffective leadership ability and experience.
  6. Demonstrated ability to effectively manage multiple priorities in a fast-paced deadline-driven environment.
  7. Strong organizational, written and verbal communication skills.

 

Education Requirements:

  1. Bachelor’s degree in Science or Engineering.

 

Physical Requirements and Working Conditions:

1.      Typical office environment.

2.      Must be able to use basic office equipment:  computer, printer, copier, telephone, etc.

3.      Must be able to remain stationary for long periods of time.

4.      Must be capable of communicating with stakeholders through various methods.

Application Process:
Interested candidates should send their resume to: 

Bob Mello
VP, Chief Operating Officer
Advanced Instruments, LLC
2 Technology Way
Norwood, MA  02062
robertm@aicompanies.com

 

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.





Quality Assurance Specialist
Advanced Chemical Company
Posted: 11/28/17

1.     Purpose and Scope:

The purpose of this Position Description is to describe and define the position of the Quality Assurance Specialist within Advanced Chemical Company. 

1.1 Reference Documents:

  ACQM-A (Organizational Chart).  
Provision of Resources (Employees) (ACOP 6.2.1).

Competence and Training (Employees) (ACOP 6.2.2).

2.     Responsibility & Authority:

The individual holding the position of Quality Assurance Specialist is responsible for, and authorized to address, all issues related to the administrative aspects of the organization’s quality system.

3.     Reporting Relationships:

Refer to Advanced Chemical Company’s Organizational Chart. (ACQM-A Organizational Chart)

4.     Reports to:

Regulatory & Management Systems Representative

5.     Main Job Tasks and Responsibilities:

·       Acts as a document custodian of all QMS controlled literature.

·       Draft quality assurance policies and procedures.

·       Interpret and implement quality assurance standards.

·       Devise sampling procedures and directions for recording and reporting quality data.

·       Review the implementation and efficiency of quality and inspection programs.

·     Plan, conduct and monitor testing and inspection of raw materials, manufactured products, and refining processes, to achieve desired outcomes.

·       Conduct and document internal audits and other quality assurance activities.

·       Investigate customer concerns and non-conformance issues.

·       Collect and compile statistical quality data to show trends or identify areas of improvement.

·       Manage all aspects of the certified Quality Management System (QMS).

·       Identify training needs and organize training interventions to meet quality standards.

·       Coordinate and support on-site audits conducted by external providers.

·       Evaluate audit findings and implement appropriate corrective actions.

·       Assure ongoing compliance with quality and industry regulatory requirements.

·       Manage supplier performance and effectiveness through the Supplier Evaluation Program.

·       Facilitate the organization’s calibration activities.

·       Actively participate in LEAN events.

 

6.     Desired Competencies, Skills, Experience and Knowledge:

·       Associates/Bachelors Degree Preferred, or 3 – 5 years of related job experience.

·       Knowledge of tools, concepts and methodologies of Quality Assurance.

·       Quality inspection, auditing, and testing experience.

·       Knowledge or relevant regulatory requirements.

·       Strong computer skills including Microsoft Office applications.

·       Attention to detail.

·       Communication skills – verbal and written.

·       Data collection, management and analysis.

·       Planning and organizing.

·       Problem analysis and problem-solving abilities.

 

7.     ISO and Associated Management System Contributions:

·       One of the primary contributors in the company’s effort to sustain compliance to ISO 9000 requirements.

·       Advocate of quality in all aspects of operation on a day-to-day basis.

·       Advocate of continual improvement (training).

The desired candidate should have a minimum of 3 - 5 years of QA experience, and the salary range will be 45k - 55k; benefits, 401k, and vacation time, are all offered. 


Please apply with resume to:

Shaun P. Galligan
Phone:  
800-553-3568
Fax:       401-941-9210
Email:   
sgalligan@advchem.com  



Quality Assurance Technician Lead
Nordson Corporation
E. Prov. RI

Posted 11/22/17

ESSENTIAL JOB DUTIES & RESPONSIBILITIES
•Perform variable and attribute inspections on incoming product.

•Ability to read and interpret blueprints and related documents.

•Possess a basic knowledge of and ability to properly use micrometers, height gages, dial indicators, threaded ring and plug gages and various other hand­ held measuring devices.

•Operate Video Measuring Equipment, Microscopes and Optical Comparator.

•Familiar with functional testing methods such as Hydrostatic Testing, Impact Testing and various destructive testing.

•Read various sampling plans and document findings in accordance with company policy and procedure.

•Knowledge of MRB process and disposition materials.

•First article inspections - Perform variable and attribute inspections on new products and document findings in Microsoft Office Word and/or Excel.

•Perform calibration of all variable and attribute inspections. Use the Inspection database to document findings, enter new instruments in the database, remove items from service, manage calibration schedule and maintain records and certificates of calibration.

•Perform EFD internal audits.

•Statistical Process Control as it applies to production runs, Quality Assurance studies, first articles and capability studies. Create SPC data charts for Cp studies and assignable cause investigations.

•Problem Solve, trouble-shoot problems, assist engineering and/or manufacturing in production or customer complaint issues in order to find assignable causes.

•Serve as back up for solder QA technician.

•Perform all other duties as assigned



EDUCATION & EXPERIENCE REQUIREMENT
•Associates degree or equivalent.
•Minimum of 5 years of prior QA experience or equivalent.
•Ability to speak, read and write English.
•Intermediate level proficiency in Microsoft Office Suites.
•Ability to apply concepts of basic algebra and geometry
•Must be able to use gages such as calipers, and micrometers
•Must be able to read engineering drawings and have knowledge of GD&T.
•Ability to work with others in a team environment.
•Must be comfortable working with chemicals.

PREFERRED SKILLS & ABILITIES
•Prior SPC knowledge.
•Experience using ERP software, SAP preferred
•Knowledge of plastic molding equipment and processes
•Experience in ISO9001:2008
•Experience using Minitab Statistical Software is a plus


WORKING CONDITIONS & PHYSICAL DEMANDS
Manufacturing and lab environment. Must have the ability to lift up to 30lbs. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Follow this link to apply: Apply here


About Nordson
Whatever you do today, Nordson Corporation is likely a part of it. We engineer, manufacture and market differentiated products and systems used for precision dispensing and processing in a variety of end markets, from packaging to transportation and medical to electronics. Founded in 1954, we operate under the values of integrity, respect for people, customer passion, energy and excellence. Nordson is headquartered in Westlake, Ohio, and has direct operations in more than 30 countries to support our products and systems with application expertise and a direct global sales and service organization.


Nordson Corporation provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status or any other status protected by applicable federal, state, or local law. All employment offers are contingent upon successful completion of our pre­ employment drug screening and background/criminal check, consistent with applicable laws.



DIRECTOR of QUALITY
Posted: 11/18/17

One of the most profitable divisions of a multibillion-dollar corporation with an very healthy backlog and more contracts on the way.

As a Member of the Management team this Quality Director will have:

  • Drive Lean Six Sigma/continuous improvement methodologies plant-wide
  • Develop and support strategic initiatives and collaborate with management continuously increase efficiencies and optimize cost
  • Responsibility for effective root cause analysis, CAPA
  • Direct communication with the customer
  • Accountability for QMS system and KPI metrics
  • maintenance of ISO9001 compliance
  • Complete audit responsibility
  • Manage 3 departments inspection, compliance, QMS (25 indirect, 3 direct)

Key requirements:

  • BS degree
  • Recent 5+ years of experience managing an ISO certified defense/aerospace manufacturing quality department
  • Experience with Lean manufacturing / Six Sigma
  • Demonstrated ability to improve quality, cost, and delivery goals
  • In-depth Problem Solving/Root Cause Analysis and risk analysis (FMEA/FTA)
  • Prior ERP system experience

Location:  Newington NH area

Compensation:  100-130 base plus bonus potential

Please contact:
Leslie Gabriele
Gabriele & Company

Recruiters for Materials and Manufacturing

781 276 7999

leslie@gabrieleandcompany.com                  
www.gabrieleandcompany.com


Director of Quality
Posted: 11/18/17

This is an opportunity to join an established company that is experiencing exponential growth.  They have introduced the “first ever” consumer medical device and projections are a 50% increase in sales in 2018. 

They have been using a ISO13485 certified contractor.  Now this corporation wants to implement an internal 13485 compliant quality management system. As the resident expert on all things quality, this Manager will:

  • Take a hands-on role in obtaining and maintaining ISO13485 certification
  • Write procedures and establish a documentation system
  • Ensure processes for ISO COMPLIANT QMS are established, implemented, documented and maintained
  • Build the quality department; train and direct quality personnel; manage budget
  • Coordinate, review, investigate and resolve complaints
  • Oversee site audits; audit documentation; findings reporting
  • Suggest and implement corrective actions
  • Participate as a Member of Senior Staff

Key qualifications required:

  • BS degree
  • At least 10 years of experience in quality
  • Track record of direct involvement/hands-on experience obtaining ISO 13485 certification
  • Prior quality management experience
  • Adept at writing procedures
  • Experience setting up 13485 quality documentation system
  • Complete understanding of manufacturing from receiving the material to shipping product
  • 5-10%  international travel

Location: Webster/Worcester, MA area
Compensation:  115-130 base + bonus

Please contact:
Leslie Gabriele
Gabriele & Company

Recruiters for Materials and Manufacturing

781 276 7999

leslie@gabrieleandcompany.com                  
www.gabrieleandcompany.com



Sensata Technologies
Posted: 11/10/2017

New Product Development Quality Inspector

Role and responsibilities:

·        Support and oversee the build of prototype samples, including developing work instructions, guiding operators, collecting and evaluating in-process data, and making final judgments on product quality prior to shipment to customer.

·        Organizing and coordinating paperwork to comply with to strict customer guidelines for documenting, packing, and shipping pre-production parts.

·        Work closely with internal support functions and external vendors to perform measurement studies, failure analysis, etc.

·        Verify compliance of incoming prototype material prior to assembly builds.

·        Acquire, analyze, and document data.

·        Procedure and technical report writing.

 

Educational requirements: Associates Degree (Mechanical or Electrical) or equivalent experience.

Professional requirements:

·        Desire to pursue additional training and education in a technical field - preferably automotive.

·        Must be detail-oriented; the position requires substantial data collection and analysis with high degree of rigor.

·        Effective time management is a critical skill for success. 

·        Highly motivated self-starter with people skills.

·        Strong Problem Solving, Interpersonal, verbal, and written communication skills.

·        Ability to organize and manage multiple projects for a team of engineers simultaneously.

·        Assist others, and to request assistance from others as needed. Many projects are high priority and have short lead times. Weekend work may sometimes be required to maintain the program schedule.

·        Familiarity with MS Excel and Word are required.  Knowledge of basic statistics will be useful.

 

If interested in this opportunity, please apply directly to this link:

Greg Johnson, Senior Technical Recruiter

gjohnson3@sensata.com

508-236-2169



CertainTeed
A St. Gobain Company
Posted: 10/19/17

Quality Manager, Norwood, MA

Through the responsible development of innovative and sustainable building products, CertainTeed, headquartered in Malvern, Pennsylvania, has helped shape the building products industry for more than 110 years. Founded in 1904 as General Roofing Manufacturing Company, the firm's slogan "Quality Made Certain, Satisfaction Guaranteed," quickly inspired the name CertainTeed. Today, CertainTeed® is North America’s leading brand of exterior and interior building products, including roofing, siding, fence, decking, railing, trim, insulation, gypsum and ceilings.

A subsidiary of Saint-Gobain, one of the world’s largest and oldest building products companies, CertainTeed and its affiliates have more than 5,700 employees and more than 60 manufacturing facilities throughout the United States and Canada. The group had total sales of approximately $3.3 billion in 2015. www.certainteed.com

Quality Manager Responsibilities:

Manages quality management system and analytical services programs and functions.

Creates and enforces quality management policies, practices, and procedures.

Manages and directs programs to ensure quality production from raw material sourcing through in-process and final inspection.

Selects, trains, directs, evaluates, and supports department personnel.

Manages departmental activities and capabilities to meet objectives within guidelines.

Coordinates projects with other departments.

Primary customer contact for resolving quality related issues.

Recommends and implements methods to improve the quality of products and/or services.

Perform other related duties as may be reasonably assigned in the course of business.


Requirements:

Bachelor Degree in an Engineering or technical discipline. Advance degree preferred.

Three or more years’ experience of quality assurance experience in a manufacturing environment at engineer or managerial level.

Demonstrated problem solving skills.

Demonstrated expertise in instrumental analysis, analytical interpretation, methodology, and statistical analysis.

Experience in managing 3rd party certifications.

Able to operate independently and as a part of a team.

Excellent communication skills, written, and verbal, including technical writing.

Computer skills necessary to fulfill requirements of position.

Strong leadership skills.

 Knowledge of ISO 9001 Quality System Standards.

 ISO9001 trained internal auditor.

Self motivated worker, able to set priorities.


Please respond with resume to Dave Gilvary

Dave.Gilvary@saint-gobain.com



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