Join our Talent Network
Skip to main content

Associate Production Compliance Engineer

Location: Durham, United States
Position Type: Unfixed Term
Job Function: Quality

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

 

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.

 

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

Share: share to e-mail

Similar Jobs

Sr. Director, Quality

Durham, United States
Quality

Associate Production Compliance Engineer

Durham, United States
Quality

Manager, Quality Floor Support

Durham, United States
Quality

Quality Coordinator

Durham, United States
Quality

Quality Floor Support - 1st Shift

Durham, United States
Quality