Quality Engineer - Data & Product Performance
Location: Arden Hills, MN 55112
Job Type: Hybrid (3 days onsite: Tuesday, Wednesday, Thursday - AH)
Pay: $37 an hour or about $76,000
Employment Type: Long Term Contract to Perm
- This is an entry level role. It is open to new grads with internship experience
About the Role
This Quality Engineer role focuses on data-driven analysis of post-market product performance. You will investigate product complaints, monitor trends, and collaborate cross-functionally to mitigate risk, improve patient safety, and enhance product performance. Note: This role does not involve hands-on product work.
The CRM Division is a collaborative team committed to leveraging data to make informed decisions and improve outcomes.
Key Responsibilities
- Apply BSC's Core Values: Caring, Meaningful Innovation, High Performance, Global Collaboration, Diversity, Winning Spirit.
- Review returned product lab analysis, customer feedback, and historical data to ensure proper coding and classification of complaints.
- Perform complaint investigations per local and global processes.
- Analyze post-market surveillance data for trends, patterns, and anomalies; query and bound data to support documentation releases.
- Respond to Competent Authority Requests.
- Present product performance data to management committees, design teams, and customers (directly or via sales).
- Contribute to process improvement initiatives and tactical team strategies.
- Conduct statistical data analysis for Product Performance and Risk Management documentation.
- Lead or participate in cross-functional projects, including planning timelines, roles, and resources.
- Adapt to evolving responsibilities and new product lines.
- Promote a diverse and inclusive workplace culture.
Minimum Qualifications
- Bachelor's degree in Engineering, Mathematics, or related field.
- Internship to 3 years of relevant experience.
- Strong analytical and problem-solving skills; proficiency in applied statistics.
- Ability to manage projects independently and meet deadlines.
- Knowledge of quality system processes and procedures.
- Strong written and verbal communication skills.
- Passion for collaborating on a team that solves problems collectively.
Preferred Qualifications
- Engineering degree with 2+ years of medical device experience.
- Technical understanding of medical device therapy products.
- Experience in Hazard Analysis, Risk Assessment, trend management, CAPA investigations, and field assessments.
- Strong technical writing skills.
- Familiarity with post-market complaint tracking, trending, and regulatory requirements.
- Project experience collaborating with Medical Safety, Design Assurance, Return Product Analysis, Supplier Development, and Manufacturing.
The base pay range listed reflects what we reasonably expect to offer for this role. Actual pay may vary based on location, experience, and performance. Depending on the position, benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs.
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