Senior Manager, Quality Assurance

JOB TITLE

Sr. Manager, Quality

BUSINESS TITLE

Sr. Manager, Quality

BAND

MMT

BUSINESS UNIT / FUNCTION

Quality

JOB CODE

QAMM20

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 (Master’s 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.