Senior Quality Engineer

Shoulder Innovations • Grand Rapids, MI

29d

About The Position

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:

Requirements

• 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
• 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

Nice To Haves

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

Responsibilities

• 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.

Benefits

• We value and appreciate our employees and will support you with great company culture, opportunities for professional growth, competitive wages, and benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level