Associate Production Compliance Engineer
Associate Production Compliance Engineer
Posted on :
10-04-2025
Employer Active
1 Vacancy
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Job Description
Benefits at bioMerieux:
- Lowcost 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 $10000 per calendar year
- Onsite cafeteria with daily food stipend
Position Summary:
The Production Compliance (PC) Engineer is primarily responsible for working within the bioMrieux 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 Whys DMAIC Ishikawa KepnerTregoe)
- 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:
- Bachelors Degree in a science or engineering field with 03 years of work experience in related industry or equivalent.
- In lieu of a Bachelors Degree an Associates 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 problemsolving skills.
- Preferred understanding of quality management tools and techniques 5 Whys Pareto Analysis 5ME 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.
Required Experience:
IC
Employment Type
Full Time
Key Skills
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