I am reaching out as you have been in touch with Experis previously and I am hoping that you might have contacts in your professional network who might be interested in an exciting new opportunity. I would like share some of the details of the role we are currently hiring for. It is a 10+ months contract as Quality System Engineer II located in Maple Grove, MN with a major medical device company.
I have included the detail of the opportunity below for your review. If you are not in the market for a new opportunity, please let me know if you have someone that might be a good fit.
I appreciate you taking the time to review this, and I hope to hear from you soon.
Job Title: Quality System Engineer II
Location: Maple Grove, MN
Duration: 10+ Months (possibly extension)
- Quality Engineer II to be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.
- Each employee can make a difference at St. Jude Medical and has the power, either individually or as a team, to influence the success of the company.
- We are team-oriented, fast-paced, and progressive.
- We value people with great ideas who partner with others both internally and externally to act and accomplish goals.
- Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
- Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
- Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Design and conduct experiments for process optimization and/or improvement.
- Appropriately document experiment plans and results, including protocol writing and reports.
- Lead process control and monitoring of CTQ parameters and specifications.
- Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
- Lead the investigation, resolution and prevention of product and process non-conformances. Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
- Lead in the completion and maintenance of risk analysis.
- Work with design engineering in the completion of product verification and validation.
- Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Performs other related duties and responsibilities, on occasion, as assigned.
Kushagra Mohan I
Talent Acquisition Specialist
[ Phone number blocked ] , [ Link Removed ]
100 Manpower Place | Milwaukee, WI 53212