Senior Quality Engineer

Shoulder Innovations is a medical device startup that is revolutionizing shoulder replacements. Led by a seasoned team with over a century of orthopedic expertise, we’ve developed a disruptive shoulder replacement system and secured substantial funding to drive rapid growth. (NYSE: SI).  

We’re seeking entrepreneurial talent to join us on this exciting journey. Our culture is built on:

• People First: Authentically human.

• One Team: Empowered and aligned.


• Innovation: Bold, creative, and daring.


• Growth Mindset: Always curious.

Ready to make an impact in orthopedics? Let’s grow together!

We are seeking a Senior Quality Engineer who is responsible for supporting supplier management, the engineering design team in sustaining activities, identifying continuous improvement opportunities, supporting complaints, and CAPA & project ownership.

In addition, your responsibilities will include, but are not limited to the following:

• Evaluate and approve supplier deviation and change requests for risk and compliance.


• Support evaluation of suppliers including but not limited to audit support & capability assessments.


• Support review of manufacturing supplier documentation, as needed.


• Maintain and update the Post Market Surveillance (PMS) Report in accordance with regulatory requirements.


• Analyze complaint data to identify trends and opportunities for product or process improvements.


• Collaborate with internal teams to implement corrective actions based on post-market insights.


• Lead CAPA investigations, including root cause analysis, action planning, and effectiveness verification.


• Facilitate cross-functional CAPA teams and ensure timely closure of quality issues.


• Maintain CAPA documentation in compliance with internal procedures and external regulations.


• Provide guidance on complaint investigations to determine probable cause as needed.


• Lead complaint investigations, coordinating with engineering, manufacturing, and quality teams as necessary; Document findings and contribute to regulatory reporting as needed.


• Perform engineering tasks involving complex design constraints, material challenges, and coordination requirements.


• Apply conventional engineering practices to resolve non-standard problems and support product lifecycle activities.


• Work closely with Engineering, Procurement/Supply Chain, Manufacturing, and Quality Assurance teams on projects.


• Provide technical input and quality oversight to ensure project success and regulatory compliance.


• Take a leading role in projects for continuous improvement, business, and/or compliance needs; Including project planning, execution, and management.

We believe to be successful as a Senior Quality Engineer; you will have the following:

• Bachelor’s degree in mechanical, biotechnology, bio-medical, industrial, or similar engineering disciplines


• 5+ years of experience in Quality Assurance, at a multidisciplinary Medical Device Company


• Familiarity with medical device regulations (ISO, EU, CFR)


• Working knowledge of FDA 21 CFR 820 regulations, ISO 13485, ISO 14971, and CGMP Good manufacturing Practices


• Knowledge of continuous improvement processes and methods


• Certified Quality Engineer (CQE) or other similar quality/reliability certifications a plus


• Great communication, both verbal and written


• Extremely organized, detail oriented, and can prioritize and execute multiple tasks in a high-pressure environment


• Strong Understanding of product lifecycles


• Strong ability to work independently


• Ability to write reports, business correspondence, and procedure manuals


• Ability to travel to suppliers as needed

If you are looking to further your career in a pioneering and evolving industry, apply today for our Senior Quality Engineer position. We value and appreciate our employees and will support you with great company culture, opportunities for professional growth, competitive wages, and benefits. To learn more about us, visit us online at https://shoulderinnovations.com.