Sr. Product Quality Engineer; V&V

Sr. Product Quality Engineer (V&V)

Location:

Atlanta, GA

The Sr. Product Quality Engineer will serve as a technical representative providing design quality expertise to a product development team. The role requires maintaining a strong collaborative partnership with cross‑functional team members to achieve patient/user safety, customer satisfaction, and organizational success. The individual will lead a risk management team and may work on other quality activities.

• 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 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, vendor qualifications, and biocompatibility and sterilization qualifications.
• Support audits and quality system improvement activities.
• Support company initiatives identified by management and support Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.
• Comply with Client, U.S. FDA, EUMDR and other applicable requirements.
• Maintain positive and cooperative communications with all levels of employees, customers, contractors, and suppliers.

• Bachelor's degree in engineering or a related 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 or a related technical field.
• Experience with active implantable medical devices.
• Knowledge of requirements management tools (e.g., DOORS) and problem reporting systems (e.g., JIRA).
• Working knowledge of statistics and its application to verification and validation.

• Seniority level:
  Associate
• Employment type:
  
  Contract
• Job function:
  Quality Assurance
• Industry: Pharmaceutical Manufacturing