Sr. Engineer Maintenance Compliance
Location: Saint Louis
Posted on: May 24, 2020
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
- 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
- Leads or facilitates team to provides appropriate team support
in cross functional projects and activities, when
- 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
- 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
- Trend department deviations, ensuring compliance of all records
to quality standards/procedures including the investigation of any
unexplained discrepancies, non-conformities, audit findings, or
- 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
- 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,
- 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
- 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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