The Sr Quality Engineer develops, implements, and maintains quality engineering methodologies, systems and practices which meet Physiologic Devices Inc., (PDI) Quality and regulatory requirements. Provide quality engineering support in the design, development, and manufacture of the PDI’s products to ensure that the products conform to established specifications and consistently meet or exceed the requirements of our customer and patients.
Reports to: Sr Director of Quality
TO APPLY: Send Resume/CV and Cover Letter explaining your fit with this position via email to: firstname.lastname@example.org.
- Works with Product Development and Operations teams to establish quality requirements at all phases of product/process development and manufacturing.
- Work with Product Development on product V&V activities including sterilization, packaging/labeling, transit testing, real time/accelerated aging as well as creation of protocols and reports.
- Work with Product Development on the Risk Management Process and maintains the Risk Management File.
- Responsible for the Design History File, device Master Record and its maintenance.
- Responsible for materials inspection such as incoming, First Article Inspection, and final product release.
- Responsible for documenting of product discrepancies and follow up on NC implementation and closure.
- Responsible for all supplier management activities including sourcing and qualifying suppliers, maintaining the Approved Suppliers List (ASL) and associated files, and managing the Supplier Corrective Action Request (SCAR) program.
- Responsible for CAPA management from CAPA generation to implementation of corrective action, verification of effectiveness, and closure.
- Assists with internal audits. Assists with hosting external audits and drive all issues to closure if need be.
- Responsible for product packaging/labeling and ensuring all materials are conforming with applicable regulations.
- Other duties as assigned.
- BS degree in Engineering or Chemistry related discipline preferably with Master in related engineering field or Chemistry field. Materials/Pharmaceutical experience is a plus.
- 5 to 8 years experience as a Quality Engineer or in related field in the medical device Industry or combination product. ASQC CQE is a plus.
- Experience with design control is a must
- Experience with software and firmware V&V is preferred.
- Applies regulatory requirements such QSR, MDR, ISO and generate procedures in compliance with regulations
- Excellent people skills, team oriented
- Excellent problem-solving skills
- Effective written and verbal communication and organizational skills Be able to coach others or teach the proper use of quality tools and problem solving techniques.