Quality Engineer

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.
• Must be a green card holder or a U.S. citizen.

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 a 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.

Employee Benefits

Medical, dental, vision, and pet insurance | 401(k) Retirement Savings Plans | Employee Assistance Program (EAP) | Commuter/Parking Accounts | People Perks | Health Savings Account (HSA) | AD & D Insurance

Are you ready to try something new? Click 'Apply Now' to submit your resume and connect with a recruiter!

After you have applied, download our Staffmark Group WorkNOW App to receive real-time job offers and apply for additional opportunities. You can download it from the App Store or get it on Google Play.

Advantage Technical connects top- talent in technology, engineering, and technical fields with forward-looking companies.

Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.