What are the responsibilities and job description for the Quality Engineer position at Shoulder Innovations?
Shoulder Innovations is a venture-backed 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.
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 Quality Engineer who wants to use their knowledge to help grow our venture capital-backed business. Someone who is experienced in design, R&D, audits, very organized, and a strong self-starter would be a perfect fit.
As a Quality Engineer, some of your job duties will include:
- Investigate complaint trends and assess complaint data for continuous improvement opportunities
- Support supplier management by assessing deviation requests, reviewing document change requests, performing interim manufacturing document reviews
- Maintain the Post Market Surveillance Report
- Take CAPA ownership and lead CAPA teams to address issues
- Support complaint investigations, as required
- Performs work which involves conventional engineering practice but may include a variety of complex features such a conflicting design requirement, unsuitability of standard materials, and difficult coordination requirement
- Work cross-functionally on projects
- Identify and lead continuous improvement activities
- Other tasks as directed by Quality Department Head
To be successful as a Quality Engineer, you will have the following experiences and skills:
- Minimum Bachelor’s degree in scientific discipline and 3 years of related work experience or an equivalent combination of education and work experience
- Working knowledge of FDA 21 CFR 820 regulations, ISO 13485 and ISO 14971
- Detail-orientated with the ability to multi-task
- Exceptional drive, work ethic and initiative
- Energetic and enthusiastic personality who thrives on diversity and challenge in a role
- Must be able to work collaboratively and operate in a fast-paced environment
- Strong working knowledge of MS Office
- Excellent analytical and problem-solving skills
- Proficient written and verbal communication skills
- Solid organizational and time management skills
- Ability to be independently motivated
- Knowledge of continuous improvement process or methods, a bonus.
If you believe that you are a perfect fit to join our team as a Quality Engineer, please consider applying today. To learn more about what Shoulder Innovations does, please visit us at www.shoulderinnovations.com.
