Sr. Quality Engineer
We are partnered with a young Medical Device company in St. Paul that is looking to add a Quality Engineer. This role will be 70% focused on their new product line, and 30% on their products already to market. If you enjoy being part of close knit team and making an impact at small company this could be the role for you!
- Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
- Identify requirements for verification and validation and reliability testing.
- Develop product Design History Files (DHR), Technical Files, Device Master Records (DMR), and FMEAs.
- Provide quality review of process validation and test method validation protocols and reports.
- With Regulatory, ensure all documentation meet the requirements of Regulatory Filings and Technical files for CE filings.
- Provide statistical guidance to test protocols/reports and ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
- Plan schedule and complete projects in an aggressive sense of urgency manner consistent with corporate objectives.
- Provide quality review of manufacturing documentation, including following lot release procedures for shipping product to customers.
Desired Skills and Experience
- Education- Bachelor’s Degree in engineering or related field
- 3+ years minimum experience in medical device or pharmaceutical industry
- Ability to understand specifications, tolerances, and units and use standard measurement equipment
- Familiar with QC sampling plans
- Knowledge of FDA, GMP, and ISO 13485 compliance requirements
- Familiar with the product life cycle of medical device development
ABOUT SKYWATER SEARCH
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Led by a group of seasoned search industry professionals, SkyWater Search Partners brings new focus to a novel concept, “Short List Search.” Our purpose is to leave a lasting impression on the clients we serve by providing individuals who will make a measurable difference in their business. We strive to consistently deliver great results to our clients in a very timely manner.
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