Quality Engineer 2nd shift- Sturgis, MI

• Production areas that are clean, well-lit and temperature-controlled
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs, Medical Benefits start day 1
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• Vacation – 3 weeks of accrued vacation (1st yr is prorated) + vacation buy program + 3 personal days + 10 paid holidays
• Company Paid Pension Plan
• 401(k) retirement savings with a generous company match
• Tuition reimbursement, the

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
• A stable company with a record of strong financial performance and history of being actively involved in local communities

• 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, coach, and mentor non-exempt and entry level exempt personnel
• 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 nonconformances
• 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 Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

• Bachelor’s Degree plus 2-5 years of relevant experience in Quality Assurance, Manufacturing or Engineering experience OR Master's Degree plus 1-3 years of relevant experience in Quality Assurance, Manufacturing or Engineering
• Demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA, GMP
• Strong project management and leadership skills
• Advanced computer skills, including statistical/data analysis and report writing skills. Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.

• Experience working in a broader enterprise/cross-division business unit model
• ASQ Certified Quality Engineering Certificate

Abbott