Benefits at bioMerieux:

• Low-cost medical, dental, and vision benefits starting day one
• 11 paid holidays
• 160 hours of paid time off
• Annual bonus
• 9.5% 401k company contribution with no vesting period
• Tuition reimbursement up to $10,000 per calendar year
• Onsite cafeteria with daily food stipend

Position Summary:

The Production Compliance (PC) Engineer is primarily responsible for working within the bioMérieux Quality Management System (QMS) to ensure the overall quality of manufactured products. This is accomplished through conducting technical investigations either independently, as a team leader, or as part of a team to support Operation initiatives. Investigations will range from quality to process improvements.

Primary Duties:

• Supports process and product failure investigations using a Quality skillset to follow industry standards to determine root cause (e.g. 5 Why's, DMAIC, Ishikawa, Kepner-Tregoe)
• Drives, or partners to drive, corrective actions to appropriately improve, fix or prevent root causes. For example, using investigation output to drive a work order or change control to address identified correction/prevention.
• Gains process knowledge to apply to job function and support cross functional teams/projects
• Gathers process and product performance data to identify trends to aid in solving product and process problems.
• Designs and conducts statistically valid scientifically sound feasibility studies to support investigations, and prepare timely written updates and report of these activities.
• Supports CAPA actions resulting from nonconformance investigations, complaint investigations, internal quality audits and other relevant functions
• Displays critical/logical thinking and collaborates across departments in completing assigned continuous improvement actions and projects.

Knowledge, Skills, and Experience:

• Education and Experience:
  • Bachelor's Degree in a science or engineering field with 0-3 years of work experience in related industry or equivalent.
  • In lieu of a Bachelor's Degree, an Associate's Degree with a minimum of ≥ 3 years of progressively responsible and related work experience in related industry or equivalent.
• Knowledge and Skills:
  • Familiarity with relevant domestic and international regulations and industry standards (e.g. ISO, FDA, QSR).
  • Exhibits strong analytical, attention to detail and problem-solving skills.
  • Preferred understanding of quality management tools and techniques (5 Why's, Pareto Analysis, 5M+E, Is/Is Not, etc).
  • Must have strong verbal communication and technical writing skills.
  • Demonstrates the ability to work well in a complex, diverse environment both independently and on a team.
  • PC skills, including proficiency in: Microsoft Excel, PowerPoint, Outlook and Word. Statistical software experience preferred.

Job ID: 40351

Nearest Major Market: Durham
Nearest Secondary Market: Raleigh