Senior Quality Assurance Engineer

Location: Minneapolis, MN
Description: Our client is currently seeking a Senior Quality Assurance Engineer for a 12 month + contract.

Requisition Note: Only local candidates or someone willing to relocate. Candidates must be onsite fulltime.
Medical device experience is highly preferred.
Description/Comment: Develops and implements methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed. Designs and installs sophisticated testing equipment and performs product testing and analysis to maintain quality levels and minimize defects and failure rates. Analyzes reports and defective products to determine trends and recommend corrective actions. Collaborates with supplier representatives on quality problems, ensures that effective corrective actions are implemented and contributes to supplier quality improvement programs. This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires attention to detail in making evaluative judgements based on the analysis of factual information. This job typically requires a degree or equivalent and a minimum of 2 or more years experience.

Additional Job Details: Position Overview (position will be onsite): Provide quality and manufacturing engineering support and direction in quality assurance, control and preventative activities within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Ensure compliance to regulation and standards. This is a critical quality engineering role to support manufacturing at Plymouth.
Responsibilities: ??? Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following: ??? Work closely with operations and the business functions to ensure quality performance of product and processes. ??? Owner of NC & CAPA activities and mentor in problem solving and root causing activities.??? Develop and manage Proposed Change Agreements (PCA) for process/design improvement project. ??? Assist in the development, responsible for review & approval of process and equipment validation/qualification. ??? Review and approval of change management activities. ??? Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation. ??? Proficiency in and makes continuous strides towards optimization of inspection methods and sampling. Support First Article Inspections. ??? Proficiency in statistical methods and application. ??? Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise ??? Responsible for initiation, management and support of Ship, Product Holds, potential product escapes. ??? Proficient in process validation activities including IQ, OQ, and PQ. ??? Work with manufacturing engineering team to ensure the quality of our product meets or exceeds our quality standards in terms of yields and scrap
Basic Qualifications: ??? Bachelor's Degree ??? Minimum 2 years' engineering or quality experience
Preferred Qualifications: ??? Bachelor's Degree in Engineering preferred ??? 2+ years' quality engineering experience in medical device or similar highly regulated industry
Contact:
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