Sr. Product Quality Engineer

Job Description

This position is Non‑exempt. Hours over 40 will be paid at Time and a Half.

The Sr. Product Quality Engineer will serve as a technical representative providing design quality expertise to a product development team. Responsible for maintaining a strong collaborative partnership with cross‑functional team members to achieve patient/user safety, customer satisfaction, and organizational success. This individual will be leading and managing a risk management team but could also work on other items. Looking for someone well‑rounded from a development quality perspective.

• Lead and/or support on‑time completion of Design Control deliverables.
• Support the establishment of objective, measurable, and verifiable product requirements.
• Support Design Verification and Validation planning & execution, including any cross‑functional investigation & resolution activities.
• Lead Risk Management activities from product concept through commercialization.
• Support test method development and lead test method validation activities.
• Support manufacturing process development & qualification for new product and design changes.
• Support the establishment of component specification definitions, supplied component sampling plan development, and vendor qualifications.
• Support biocompatibility and sterilization qualifications.
• Support audits and quality system improvement activities.
• Support Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.
• Comply with Client, U.S. FDA, EUMDR and other requirements, as applicable.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers.

• Bachelor’s degree in engineering or technical field.
• Minimum of 5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality with at least 2 years supporting product development.
• Experience in medical devices and associated regulations/standards.
• Experience in test method development and validation.
• Experience in preparing risk assessments, FMEA and other risk documents.
• Advanced degree in Engineering/Technical Field.
• Experience in active implantable medical devices.
• Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA).
• Working knowledge of statistics and its application to verification and validation.

Associate

Contract

Quality Assurance

Pharmaceutical Manufacturing