Job: Quality Engineer

Title Quality Engineer
Categories Engineering
Location South Metro
Job Information

SkyWater is looking for a Quality Engineer for a client of ours south of the cities. This would be a full time permanent opportunity.

Job Description:

  • Identifies and implements effective risk management and process and design control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external quality and regulatory requirements.
  • Lead the implementation of assurances, process controls, and CAPAs / systems designed to meet or exceed internal and external requirements.
  • Act as team member in supporting quality disciplines, decisions, and practices.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Assure the development and execution of streamlined business systems, which effectively and efficiently comply with procedural and regulatory requirements and are robust to identify and resolve quality issues.
  • Advise management on potential improvements or enhancement to quality systems and processes in the company.
Desired Skills and Experience:

Skills and Qualifications:

  • BS in Mechanical, Electrical, or Biomedical Engineering.  MS degree preferred.
  • Minimum of 3 years of Medical device design controls and risk management experience required.
  • In depth familiarity with the FDA, ISO, MDD and the medical device industry quality requirements associated with product design & development and product risk management.
  • Detailed understanding of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, and EN ISO 14971.
  • Strong communication (oral and written) and presentation skills.
  • Familiar with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).
Job ID# 877
About Skywater Search Partners

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.

Practice Expertise:

– Accounting and Finance

– Consumer Package Goods (CPG)

– Engineering

– Human Resources (HR)

– Information Technology

– Operations

– Sales and Marketing

– Supply Chain

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.

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