Rhode Island Section 0107 of the American Society for Quality


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Position: Quality Systems Engineer or Specialist
Posted: 12/8/18


Ximedica is an EN ISO 13485 certified and FDA registered full-service product development firm with offices headquartered in Providence, and with locations around the world. We have an exclusive focus on medical products and over 25 years of experience developing medical devices, combination products and consumer healthcare products.

We have a close-knit, high-energy culture that fosters the creative spirit while exceeding client expectations.  We offer tremendous opportunity for professional development and leadership, rewarding projects, competitive salaries, an excellent benefits package, and summer hours.



Position:  The Quailty Systems Engineer or Specialist  provides company leadership in the maintenance and improvement of corporate-wide quality management systems and support processes.  S/he proactively manages the various elements of the quality system to ensure compliance to applicable national and international quality system regulations.  This position reports to the Quality System Manager.

Timeframe and Location:  1 FTE, Providence location.

Requirements: 
  • Must have good written & oral communication skills and the ability to communicate appropriately with different engineering teams, Project Management, clients, and customers.
  • Strong investigational and communication skills, with a strong skillset to document investigations, perform root cause analysis, and determine corrective action plans
  • Demonstrated working knowledge of Quality Management Systems requirements and process ownership, preferred.
  • Certified Internal Auditor, preferred
  • Technical Writing Experience
  • Experience with Value Steam Mapping and Overall Process Improvement
  • Experience with performing GAP analysis (i.e. translating regulations into Ximedica SOPs)
  • Direct experience with ISO 13485 and FDA QSRs

Education: Bachelors Degree or higher in an Engineering discipline or equivalent experience

Experience: Minimum of 3 years relevant experience in Quality Systems in a new product development, medical device, environment

Responsibilities:

  • Support the Quality Systems Manager to provide hands-on ownershipfor the various elements of the Ximedica Quality Management System including corrective and preventive action (CAPA), customer complaints, and/orinternal audits etc. to ensure successful performance during third-party audits
  • Ownership of  CAPAs, customer complaints, audit findings, and/or internal audits
  • Ownership and/or contributor to process improvements
  • Compile and track appropriate metrics and data to demonstrate Quality Management System compliance
  • Support Quality Systems Coordinator in following up and ensure timely closure of CAPAís, Audit Findings, etc.
  • Ability to support monthly operations meetings by compiling and presenting metrics
  • Review and approve Internal and External audit reports, as well as any audit findings
  • Perform Risk Assessments for quality observations
  • Ability to perform Quality System Software Validations, as needed
  • Other responsibilities as assigned by direct supervisor
  • Other responsibilities as assigned by your supervisor.

EQUAL OPPORTUNITY EMPLOYER
It is the policy of Ximedica to provide equal employment opportunities to all qualified applicants and employees regardless of race, color, religion, gender, age, national origin, sexual orientation, veteran status, disability that can be reasonably accommodated, or any other basis prohibited by federal, state, or local law.


Please
apply for the position through the Ximedica website:
http://www.ximedica.com/about/careers
or e-mail a resume and include in the e-mail the position you are applying for to evoegeli@ximedica.com


Position: Document Control Managerbr>Posted: 12/8/18


Ximedica is an EN ISO 13485 certified and FDA registered full-service product development firm with offices headquartered in Providence, and with locations around the world. We have an exclusive focus on medical products and over 25 years of experience developing medical devices, combination products and consumer healthcare products.

We have a close-knit, high-energy culture that fosters the creative spirit while exceeding client expectations.  We offer tremendous opportunity for professional development and leadership, rewarding projects, competitive salaries, an excellent benefits package, and summer hours.


Position:  The Documentation Control Manager leads and manages all aspects our Ximedicaís Document & Record Management systems in compliance with QSR/ISO 13485.

Nature of Role:  The Documentation Control Manager is responsible for the overall management of the documentation control system for Ximedica.  This includes supervision and execution of all Documentation Control activities, and personnel engaged in those activities, including the change control process, quality records archiving, etc. The position interfaces with other departments and teams to give guidance and direction to ensure that documentation complies with Ximedica standards and regulatory requirements.

Requirements: 
Detail-oriented, energetic self-starter with strong communication and organizational skills.  The successful candidate will have a proven ability to multi-task and work collaboratively as well as independently in a dynamic and entrepreneurial environment.  The position requires a minimum of 5 years of experience in a documentation control role, and experience in management, in a Medical Device/Health Care organization. Additional qualifications are as follows:
  • A Bachelorís degree or equivalent experience in Documentation Control in a design, development and manufacturing environment.
  • Thorough understanding of document control, configuration management and engineering change control processes (e.g., part numbering, releases and versioning, naming conventions, record management, etc.)
  • Working understanding of the principles of Medical Device and healthcare regulations including FDAís Quality System Regulation (QSR) , ISO 13485, etc, including Part 11 compliance.
  • Excellent organizational and time management skills. Detail oriented, dependable and willing to handle multiple priorities with a high degree of flexibility.
  • Successful communication skills, business acumen and assertive decision-making ability
  • Demonstrated ability to develop, improve, and implement business processes and documentation systems.
  • Experience with implementing (preferred), using , and managing electronic Product Lifecycle Management (PLM), Product Data Management (PDM) and Document Control systems (i.e.- Agile, Trackwise, MasterControl, SmaertTeam, etc.).
  • Preferred experience in software validation.

Responsibilities:

  • Provide management oversight and expertise in document and records management and quality records management systems.
  • Manage the day-to-day engineering change control process and provide guidance and direction to company personnel on execution of changes.
  • Manage and direct the activities of the Document Control department personnel.
  • Responsible for oversight, alignment and execution of documents with internal operations and external sources to assure compliance with Quality System requirements.
  • Develop, document and promote document control best practices.
  • Own CAPAs, audit findings, and continual improvement activities as assigned by supervisor.
  • Train staff on document control processes and procedures.
  • Responsible for establishing and maintaining the global standards library.
  • Assist in the development and implementation of electronic Product Lifecycle Management (PLM), Product Data Management (PDM) and/or Document Control systems (i.e.- Agile, Trackwise, MasterControl, SmartTeam, etc.) .
  • May own and manage the quality system software process.
  • Other responsibilities as assigned by your supervisor.

EQUAL OPPORTUNITY EMPLOYER
It is the policy of Ximedica to provide equal employment opportunities to all qualified applicants and employees regardless of race, color, religion, gender, age, national origin, sexual orientation, veteran status, disability that can be reasonably accommodated, or any other basis prohibited by federal, state, or local law.

Please apply for the position through the Ximedica website:
http://www.ximedica.com/about/careers
or e-mail a resume and include in the e-mail the position you are applying for to evoegeli@ximedica.com

Quality Technician
The INSCO Group  Lincoln, RI USA
Posted: 11/14/18

Benefits Offered
401K, Dental, Life, Medical, Vision

Employment Type
Full-Time

POSITION OVERVIEW:
Facilitate day-to-day quality activities within INSCO (specifically the Niantic Seal, Inc. and D.L. Thurrott, Inc. business units). Responsibilities related to test and inspection of products, raw material, and equipment, handling of nonconforming material concerns, quality problem resolution, participation in internal quality audits (and resulting activities), and the occasional sorting of key products for determination of quality characteristics as required, in support of customer requirements. This person may interface with other internal functions, suppliers, and customers, with the goal of assuring quality of product and process, increasing customer satisfaction, and improving profitability by contributing to continual improvement.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

Interprets customer and internal engineering specifications, drawings, work instructions, procedures, and/or government and international standards, and confers with management or engineering staff as required to determine quality and reliability requirements.

Applies skills above to inspection of supplier and internally molded, stamped, and cut parts made from rubber and other materials.

Applies mechanical knowledge to inspection of assembled equipment typically used in liquid and air handling and transfer, such as pumps, hoses, etc.

Using prior experience with applicable measuring devices, selects products for test at specified stages from incoming product, during the production process, or at final inspection, and tests products for a variety of variable and attributive characteristics and qualities, such as dimensions, performance, and mechanical, electrical, or chemical characteristics.

Records test data, applying detail-oriented procedures, formats, and software.

Evaluates and reports upon data to validate or indicate deviations from requirements / standards.

Recommends modifications of existing quality or production standards to achieve optimum quality

Sets up and performs destructive and nondestructive tests on materials, or products to measure performance, or material characteristics.

Performs First Article Inspections (FAI)

Prepares outgoing customer certifications

Generates, monitors, and closes, raw material, in-process, and final inspection NCEís in accordance with SOPís

Provides input and support to internal personnel on product specification and / or customer expectations.

Proficient with, or ability to be trained in the use and operation of CMM inspection tools.

Ability to read and interpret complex blueprints and drawings, and use all basic hand measurement tools such as micrometers, calipers, steel scale, part weighing scales, etc.

Assists in the performance of internal quality audits

Visually appraises products for various attributes such as cleanliness, damage, burrs, etc

Strong attention to details and a desire to learn required.

Able to lift up to 50 lbs. on occasion.

EDUCATION and/or EXPERIENCE

High School or technical school diploma or GED, and three to five years related experience and / or training. An Associate's degree or equivalent in a technical discipline is preferred; or equivalent combination of education and experience.

Working knowledge of ISO-9001:2015. Knowledge and experience working within an aerospace products environment and applying related standards and practices such as AS9100 / AS9102, FAI, ITAR, etc highly desirable.

Experience with steel rule die and/or CNC stamping preferred.

A basic understanding of hydraulic and pneumatic principals, pumps, hose materials, and related equipment a definite plus.

Literate with Microsoft software required (WORD, Excel), and ability to quickly learn, and effectively apply, custom software applications such as Lotus Notes, SX.enterprise, Job Pack, etc.



MATHEMATICAL SKILLS

Ability to work with all basic mathematical concepts. Ability to apply knowledge such as fractions, percentages, ratios, and proportions to practical situations and everyday activities. Advanced skills such as probability and statistical inference, and fundamentals of plane and solid geometry highly desirable.


CERTIFICATES, LICENSES, REGISTRATIONS

Certifications from ASQ or other related professional organizations are highly desirable.


About The INSCO Group:
Founded in 1941, INSCO is the parent company for two specialized distribution companies engaged in the distribution of technical engineered products, systems, and fabricated parts. 

Our Niantic Seal division sells gaskets and O-rings, in addition to providing custom die-cut, fabrication and assembly services. D.L. Thurrott Inc. division sells industrial, sanitary and municipal pumps, air compressors, dryers, and blowers. We also design, custom skid packages, and sell after-market parts and service to our customers.


Please send resumes to:
Terry McManus at:
TMcManus@inscogroup.com

See our websites for additional information on our company, products and services:
www.dlthurrott.com
www.inscogroup.com

Company website: http://www.inscogroup.com/
Company address: 17 Powder Hill Road, Lincoln, RI 02865

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