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Sr. Engineer Maintenance Compliance

Company: Biom--rieux
Location: Saint Louis
Posted on: May 24, 2020

Job Description:

------------bioM--rieux Inc.

Sr. Engineer Maintenance Compliance

The Sr. Engineer Maintenance Compliance is primarily responsible for troubleshooting equipment and/or process related issues, writing and completing Non Conformity Investigation Reports (NIR) and CAPAs, initiating and overseeing change control activities, supporting customer complaint responses as needed, writing and revising SOPs and Manufacturing Directions (MD), evaluating and recommending new equipment purchases and providing input to internal and external audits.

Identify improvement opportunities and implementing changes to improve products, processes and/or reduce costs using lean manufacturing techniques and other tools.

Execution and direct management of improvement projects within the Operations and Quality functions through training, cross functional team facilitation, and project completion to achieve the required results. Project accountability from conception to completion. Tracks project status, audits results and presents updates to senior management.



  • Represent the department as the principal quality contact

  • Uses quality investigation activities, including but not limited to, nonconformance investigations, deviations, and CAPAs to ensure product and product meets requirements. Lead troubleshooting efforts to determine these root causes for failure. Utilize investigation tools such as fishbone, is / is not and 5 whys to identify investigation scope, true cause and product impact.

  • Ensures that the appropriate follow up, priorities, tracking, trending, and reports are completed in a timely manner.

  • Support department activities related to customer complaints.
  • Leads or facilitates team to provides appropriate team support in cross functional projects and activities, when applicable.
  • Works closely with all site functions to continuously improve product manufactured and the management system for the department without jeopardizing any quality.

  • Develop and maintain a competency-based quality training program which presents opportunities for both hand-on and competency-based training of quality-related tasks/procedures/processes. Training, coaching and mentoring these team members to maintain process and product quality at a high level.
  • Guidance to ensure that quality records accurately maintained in a consistent and efficient manner and oversight which ensures that current and developed procedures are appropriate.
  • Manage Continuous Improvement Activities: Drives functional strategy, the creation, update and consolidation of necessary SOPs, change control and collection of data or measurement of critical compliance values.
  • Trend department deviations, ensuring compliance of all records to quality standards/procedures including the investigation of any unexplained discrepancies, non-conformities, audit findings, or etc.
  • Participates in the development and execution of training programs (GMP, risk analysis, statistics, etc.) as needed.
  • Assist in overall GMP strategy, best practices, and guidance for the department. Process Improvement, incl. process mapping, value stream mapping
  • Performs additional job related duties, as requested.
  • Requires Bachelor's Degree in scientific or technical field.

  • 7+ years of relevant industry cGMP and ISO 9001 experience in medical devices or pharmaceuticals required.
  • Must possess expert knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. FDA, ISO, QSR, UL, CSA, VDE, etc.).

  • One or more of the following certifications is desired for this role: Certified Quality Engineering (CQE), Certified Quality Auditor (CQA), Certified Manager of Quality / Operations Excellent (CMQ/OE), or Six Sigma Black Belt.

  • Requires excellent written and oral communication skills to interface across all levels of the organization and be skilled in delivering effective presentations.
  • Must be proficient in Microsoft Office Package (Word, Excel, etc.). Must be competent in statistical data analysis, be able to manage and analyze large volumes of data, create summary reports, etc.

  • Demonstrated strengths in leadership, interpersonal skills, project management, creative thinking, problem solving, and the development of manufacturing systems and their deployment.
  • Previous experience developing and presenting quality training is desired.
  • Lifting (up to 25 lbs) office products and supplies and moving containers of various materials.

  • Excellent personal hygiene required.

    bioM--rieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA

Keywords: Biom--rieux, St. Louis , Sr. Engineer Maintenance Compliance, Engineering , Saint Louis, Missouri

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