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TERUMO_LOGO
Posted: 5/31/17

 

Senior Engineer I, Quality

Ashland, MA

 

At Terumo Cardiovascular Group, we develop, manufacture and distribute medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass, intra-operative monitoring and vascular grafting. This includes a full-line of perfusion products, endoscopic vessel harvesting products and surgical stabilization products. In addition, Terumo CV Group is the exclusive distributor of Vascutek® Vascular Grafts in the U.S.

Our parent company, Terumo Corporation, is a global medical device manufacturer focused on cardiac and vascular specialties, hospital products, and home health care. Established in 1921, Terumo Corporation has more than 19,000 associates in 82 sales offices and 24 production facilities. It provides medical devices and services for the benefit of patients and medical settings in more than 160 countries.

 

Job Summary

Senior Engineer I, Quality


This position is responsible for providing quality engineering experience and support to operations and product development engineering to investigate, plan, and implementing product quality improvements in and/or additions to current products and manufacturing processes that directly affect safety, quality, regulatory compliance, and/or productivity.

 

Responsibilities


1.      In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

2.      Provide quality engineering expertise and leadership required to plan and implement specified projects to be completed including organizing and leading projects of various departments, planning and scheduling, coordinating resources (personnel, materials, time, money, suppliers), preparing proper documentation, etc.

3.      Lead cause-identification and problem-resolution for various types of quality, production or service-related issues.

4.      Monitor and control quality processes, identify issues and ensure they are resolved.

5.      Provide guidance in the design, fabrication, development, installation, validation, and qualification of equipment / processes which may include feasibility studies and/or proper documentation for justification of project and training.

6.      Plan and implementation of quality related projects to develop, install, and qualify new processes for manufacturing new products or improving existing processes.

7.      Plan work schedules, expenditures, attend meetings, and prepare monthly reports as required.

8.      Maintain and support ESD program as required by site.  Responsibilities may include updating ESD documentation and monitoring ongoing practices.

9.      Assign, delegate, and assist in the completion of engineering tasks or projects to other engineers in the department.

10.   Perform other duties as assigned.

 

Qualifications


Requires a four-year college degree in an engineering, scientific, or technical discipline with a minimum of six years of experience in a Quality Engineering or Process Engineering role in a regulated environment or a Master’s degree with a minimum of five years of experience. In lieu of a four year degree, a high school diploma or equivalent and eleven years of quality engineering experience in a regulated manufacturing environment. Intermediate computer software skills, i.e. Microsoft Office. Industry recognized certification (e.g. CQE, CQA, PE) preferred.

 

Competencies


The duties and responsibilities mentioned in the job description are representative of the essential functions of the position.  The performance management system incorporates competencies which are identified, discussed and evaluated in order to meet operational milestones. 

Four types of competencies have been identified that are tied to job families; Sales competencies are job specific skills and methods required of our sales Associates, Core Competencies for salaried and hourly Associates are the abilities and behaviors expected of all Associates in non-leadership roles, Leadership Competencies are specific abilities and behaviors required of those performing formal management roles or other leadership roles (i.e. Project Leaders). 

 

Supervisory Responsibility


Direct:  May include one or more.

Indirect:  None.

Functional: This position supports various departments within the organization.

Working Conditions/Physical Requirements


The position exists in office and manufacturing environments within a manufacturing facility. May require gowning procedures for controlled environment. May work in lab environment with chemicals, electronic equipment, bovine and/or human blood, and/or biohazardous materials that require the use of personal protective equipment. May require the use of eye protection, hand protection, and, depending on noise level, may require hearing protection. Requires sitting for long periods of time with occasional stooping, bending, reaching, grasping, etc. May require occasional lifting, carrying, pushing, pulling, of objects up to, but not limited to, 40 lbs.  Frequent repetitive motion tasks performed. Requires travel up to 10%.

 

To Apply


To Apply, Please Visit the Careers Section of Our Website,

http://www.terumo-cvs.com/

Terumo Cardiovascular Group is an Equal Opportunity Employer


Quality Engineer
Guill Inc.
Posted: 5/20/17

Position Description: The fundamental scope of this role is to manage the quality management system along with all activities associated with Guill’s various certifications and to lead quality improvement efforts. 

Position Responsibilities:

1.      Ownership and execution of the quality management system.

2.      Coordinate all activities associated with Guill’s ISO9001:2015, AS9100D, and Military certifications.

3.      Develop product quality inspection plans to assure product meets customer requirements.

4.      Lead root cause investigation and development of corrective action plans for all customer complaints.

5.      Liaison between company and source inspectors/customers.

6.      Directs inspection and testing activities and when necessary, will perform inspection and testing activities.

7.      Collects, analyzes, and utilizes data to lead continuous improvement activities.

Position Knowledge / Skills / Requirements:

1.      Basic Requirements:

a.      Strong knowledge of ISO9001:2008 requirements

b.      Sound problem solving skills.

c.      Capable of reading and interpreting machinist blue prints.

d.      Associates degree or 5 years experience as a quality engineer.

2.      Additional Requirements:

a.      Strong ability to influence peers to drive initiatives.

b.      Solid interpersonal skills both verbal and written in dealing with others.

c.      Sound decision making including risk management.

d.      Strong organizational skills.

e.      A continuous learner.

f.       Action oriented, results driven.

3.      Preferred Requirements:

a.      5 years experience in a machining environment.

b.      Working knowledge of military specifications.

c.      Strong knowledge of AS9100D certification.

d.      Experience managing quality technicians.

e.      Experience leading continuous improvement and lean manufacturing initiatives.

 

Must be US CitizenSalary Commensurate with experience

Benefits:  Medical, Dental, Life, Holidays, Vacation, 401k and Flex Spending

“WE ARE AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER”

Resumes may be sent to: hr@guill.com


Quality Assurance Manager
Posted: 5/13/17

Swissline Precision LLC is a world-class precision CNC contract manufacturer serving the aerospace and medical industry.  We are in search of an individual to lead our QA Department.  We are both ISO 9001 and ISO 13485 certified.  We wish to begin the journey for AS-9100 in the near future as well. 

We are actively seeking a candidate that will have the following:

·        Responsibility for all aspects of the implementation and management of the company wide Quality Management System in accordance with ISO 9001 and ISO 13485. 

·        Leading the company QMS migration to the new ISO 9001-2015 and ISO 13485-2016 Standards

·        Directs the Quality Assurance and Quality Control functions.

·        Must ensure implementation and effectiveness of Internal Quality Audit System.

·        Fill the role of ISO Management Representative

·        Track and maintain data analysis of key metrics and performance data as it relates to quality strategy and results. 

·        Establishes statistical reliability by using mean time before failure, reliability modeling, and reliability demonstration tests.

·        Ability to interpret industry standards and customer specifications for shop use.

·        Drive for continuous improvements and stretch quality targets throughout the organization.


Qualifications:

·        3-5 years of experience leading and managing Quality Assurance and Quality Control efforts within a high tech precision machine organization.

·        Mechanical and Optical background required; experience with GDT, SPC, and various gaging methods.

·        Solid experience in sustaining ISO certification and maintaining ISO documentation.

·        Strength and background experience in dealing with a fast pace environment. This individual should have the confidence to take the lead when needed. 

·        Experience in formulating and maintaining a solid reliable quality system. 

·        Industry certifications are a plus.

Compensation:

·        We offer health care, dental, 401k, profit sharing, and bonuses.

·        ESOP (employee stock ownership plan). 

·        Paid Vacation Timeand various holidays offered.

·        Top competitive pay based upon individual’s capabilities.   

 

Please send resume and contact information to: inquiries@swisslineprecision.com
 

Temporary Quality Position at Materion Technical Materials, Lincoln, RI
Posted: 4-28-17

 

Responsibilities include:

Working with Incoming Inspectors and Vendors to process or return raw material that does not meet the incoming inspection criteria.

Working with Engineering Technicians to update Purchase Order Text on orders placed with vendors from our approved supplier list.

Working with Purchasing to get replacement material for orders that have been rejected.

Helping the Quality Department prepare for our recertification audit in June 2017.

General Quality support for the daily production line quality issues.


This position reports directly to the Quality Manager.

This is a temporary first shift position that could lead to full time employmen

Education experience should be an Associate’s Degree in a related field: Quality Assurance, Quality Systems, Quality Management, Engineering or Business Administration.

3+ years of experience

Please contact Kevin Martin:  Kevin.Martin@Materion.com  401-288-0622.


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