12500 Whitewater Drive Minnetonka, MN 55343 US
As the Quality Engineer-Contract, you will lead quality engineering activities for commercial and development combination products. You will also participate in quality engineering activities for commercial scale up prior to product launch and support contract manufacturing.
In this role, you’ll have the opportunity to:
• Evaluate mechanical product design and identify potential design quality issues and drive technical decisions.
• Lead and support DHF and DMR content completion, integrity, and regulatory & standards compliance; collaboratively communicating and resolving gaps.
• Lead CAPA/NCR/SCAR/complaint investigations and reports
• Supports and ensures the establishment of objective and measurable product requirements.
• Support engineering print specification definitions, development, and changes
• Lead preparation and maintenance of risk management files from product conception through post market surveillance
• Develop and maintain product release testing plans, associated test methods and procedures.
• Support design test and inspection method development and validation
• Support design verification/validation and reliability study execution
• Support contract manufacturing activities including Process Development, Process Validation (IQ/OQ/PQ), and Nonconformance Resolution
• Identifies and leads continuous improvement projects and quality systems improvements.
To succeed in this role, you’ll need:
• BS degree in an engineering or physical/life science field with a minimum of 5 years relevant experience within the medical device industry or related function (a combination of education and experience may be considered)
• Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance
• Good statistical data analysis skills
• Background in manufacturing processes for drug-device combination products related to development and commercial programs.
• Excellent verbal and written communication skills
• Ability to collaborate with internal customers, 3rd-party partners, and CMOs.
In return, we offer you:
• Hybrid work flexibility
• A collaborative, innovative team that works as one to amplify your impact on your career, the work you do and patients’ lives.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.