Sr. Quality Engineer
Located in the St. Paul area.
- 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- Master’s or Bachelor’s Degree in engineering or related field
- 5 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
Start with your Short List
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.
Our practice areas are led by highly experienced executive recruiters who take great care in fully understanding client requirements and candidate qualifications.
• Accounting and Finance
• Information Technology
• Sales and Marketing
• Human Resources (HR)
• Supply Chain
• Consumer Package Goods (CPG)
Founded on long-standing relationships and hundreds of successful placements throughout the Twin Cities business community, SkyWater Search Partners is a proven resource for clients and candidates looking to quickly and confidently explore their “short list” of best choices. Count on us to find the best people – and the best fit.