What are the responsibilities and job description for the Senior Staff Manufacturing Software Quality Engineer position at SRG?
The Senior Staff Software Quality Engineer plays a critical role in enabling the launch and long‑term production of 3D‑printed titanium orthopedic hip implants by ensuring FDA‑compliant software validation and lifecycle management. This role leads risk‑based validation of additive manufacturing software, ensures data integrity and traceability, manages controlled software changes, and partners cross‑functionally to mitigate risk, support regulatory readiness, and maintain reliable, scalable manufacturing operations.
Required Qualifications
- Bachelor’s degree in Engineering, Computer Science, or a related technical discipline (advanced degree preferred).
- Extensive experience in software quality, validation, or compliance within a regulated medical device or life sciences environment.
- Deep knowledge of FDA QSR (21 CFR Part 820) and risk‑based software validation principles.
- Experience validating software used in manufacturing, automation, MES, or data management systems.
- Strong understanding of data integrity, traceability, and electronic records in regulated environments.
- Proven ability to lead cross‑functional initiatives and influence without direct authority.
Preferred Qualifications
- Experience supporting additive manufacturing, 3D printing, or advanced manufacturing technologies.
- Familiarity with orthopedic implants or Class II/III medical device manufacturing.
- Experience supporting regulatory inspections and submissions related to software validation.