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Product Quality Engineer

3 months ago

Plymouth, United States Info Way Solutions Full time

Product Quality Engineering or Manufacturing Engineering experience


We need an engineer with good detailed Macro and Micro-engineering skill sets. Micro Engineering will be a very big part of this role.


ISO 13845


Job Description


• Act as SQE lead to drive the Supplier Qualification and Part Qualification for Vasper Products.

• Responsible for Supplier Quality Performance Monitoring of Vasper Products, assisting in the development of Quality processes relating to Supplier Quality Control’s, works with the team to assist in supplier audits and supplier qualification, assessing supplier capabilities, supplier quality controls, adherence to design outputs, audit and inspection experience, experience with supplier control and design controls, and design ties to supplier.

• Knowledge or experience with CPK, APQP, Process Capability Statistics in relation to Six Sigma which is essentially process optimization, understands QSIT, serve as a Quality interface to suppliers supporting quality and productivity goals.

• Drive supplier improvement via SQIP (Supplier Quality Improvement Plans).

• Experienced in Electro-mechanical and Stent Commodity

• Highlights risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.

• Advises team members pro-actively on technical ideas and promotes skill development of team work.

• Responsible for driving quality through design by working cross functionally with company R&D, Design Engineer, and suppliers on component and device designs.

• Possesses strong communication skills and is able to adjust style to respective audience (managers, peers, customers, executives, etc.). Makes decisions: Utilizes good judgment and makes timely decisions which consider the facts and data at hand. Knows when to escalate to management and presents possible resolutions. Takes personal responsibility to resolve issues.

• Confronts Issues: Raises issues that block the achievement of individual and team performance; voices opinions and concerns without waiting to be asked; and attempts to establish areas of difference as well as areas of common interest. Actively promotes conflict resolution.

• Influences Outcomes: Influences others to support a course of action and to incorporate quality concepts in all activities; appropriately uses authority; influences activities without reliance on formal authority; and communicates unpopular decisions in a realistic but favorable light

• Ensure all policies and processes are followed and monitor compliance to appropriate regulatory standards.

• Responsible for supplier metrics for business unit reviews


Required Qualifications

• Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Bachelor of Science Degree in Engineering Electrical or Mechanical.

• Minimum 7 years’ experience, with medical device experience required.

• Minimum three years of GMP manufacturing experience required.

• Requires demonstrated skills in technical innovation, technical leadership, mechanical and or chemical engineering, fluids engineering, and cellular biology.

• Mechanical and electronic ability aptitude to assist with equipment troubleshooting.

• Understanding of and adherence to GMP practices and FDA regulations.

• Knowledge and ability to implement FDA or regulatory requirements as necessary.

• Knowledge and use of relevant PC software applications and skills to use them effectively.

• Travel between 25-50% and some international travel possible.

• General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.