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17 days old

Medical Device, Quality Manager

Kelly Services
St Louis, MO 63103
**JOB TITLE**


Sr. Manager, Quality


**BUSINESS TITLE**


Sr. Manager, Quality


**BAND**


MMT


**BUSINESS UNIT / FUNCTION**


Quality


**JOB CODE**


**LOCATION**


St. Louis, MO


**OBJECTIVES/**

**PURPOSE OF JOB**


Ensure Quality and Compliance for Surgical Products under scope of responsibility, including Customer complaints, and representing B&L Site Quality with Notified Bodies and Competent Authorities.


Product Stewardship Champion and Site Quality leader of Enterprise Excellence and other continuous improvement programs.


Develop, maintain, and improve quality system procedures that comply with applicable B&L and regulatory standards in a medical device regulated environment.


**KEY ACTIVITIES/**

**RESPONSIBILITIES**


+ Ensure end-to-end product quality and conformance with all applicable standards and regulations.

+ Manage Quality Organization including Quality Engineering, Quality Control, Quality Assurance, Calibrations, Metrology and Validation.

+ Develops annual quality plan to deploy quality goals and objectives that are linked to B&L Global Quality Policy and corporate strategic priorities. Communicates and implements the Quality Policy.

+ Manage/control quality of product from receiving of materials, in process through finish product release. Communicate the importance of meeting customer requirements as well as regulatory requirements.

+ Designated Quality liaison with Global B&L and external contacts with regards to quality issues.

+ Utilize metrics in QPI monitoring system for process and product Quality performance to proactively identify risk, assess risk, implement mitigations when required, and drive continuous improvement.

+ Analyze workflows, process and systems to improve efficiency and effectiveness.

+ Supervision of Quality Engineering resources responsible for Medical Device Regulations readiness, including on timely completion of Quality deliverables per MDR program timeline.


**SUPERVISE DIRECT REPORTS**


_(yes or no)_


Yes


**SCOPE OF POSITION**


Primary responsibility is Quality Operations of the Bausch and Lomb sites in St. Louis Tree Court and Sovereign Court. May be requested to support other Bausch & Lomb facilities as needed.


Responsible to maintain controllable expenses under approved budget every year.


Responsible for managing a department area of 15-20, including 3-5 direct reports.


**KEY RELATIONSHIPS**


+ Internal: Functional representatives within Bausch + Lomb manufacturing facilities, corporate offices, US and International distribution centers.

+ External: External auditors/regulatory authorities, and customers.


**QUALIFICATIONS/**

**TRAINING**


Education (Required):


+ BS Engineering or Science (Masters degree preferred).

+ Knowledgeable of ISO 13485 and FDA/QSR requirements and quality system development and management. Medical Devices experience required. Knowledgeable of statistical techniques and application experience. Demonstrated project management and leadership skills, strong written and oral communication and interpersonal skills.

+ Working experiencing implementing requirements from ISO 13485, GMPs, CMDR (SOR/98-282), JPAL, MDD and MDR are required.

+ ISO 14001, OHSAS 18001, and other regulations are desired.

+ Working knowledge of FDA and International regulations, and experience with managing external agency inspections necessary.

+ Training and experience in validation, auditing, statistics (DOE, SPC) preferred. Training in problem solving techniques or Lean Six Sigma Green belt preferred.

+ Technology Skills: Windows, Word, Excel, Access, Power Point, Project, Visio, statistical software usage & principles.


Experience (Required):


+ 10+ years of experience in an End-to-End Quality leadership position.

+ Supervisory experience, minimum 7-10 years experience in FDA regulated industry in a quality discipline.

+ 10+ years of Quality Engineering and Quality Assurance experience utilizing Quality Sciences and Regulations in health sciences industry.

+ Comprehensive understanding of U.S. and International regulations and standards for medical devices.

+ Quality leader with strong ability to drive sustainable process capability who can successfully implement an Advanced Quality process and metrics.

+ High level of Technical competency in Medical Device Equipment, Disposable Devices, Device components, and accessories.

+ Proven success in maintaining manufacturing sites certifications and compliance Year-over-Year.

+ Strong Engineering/Operations Leadership skills with some experience in organization development.


**Why Kelly** **** **Engineering?**


Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the worlds most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, were here to guide you to the next step in your engineering career.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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Posted: 2022-09-19 Expires: 2022-10-20

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Medical Device, Quality Manager

Kelly Services
St Louis, MO 63103

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