Quality Control Supervisor

Precision Life Sciences - Westchester, PA

Quality Control Supervisor 

 

JOB DESCRIPTION:

Position: Quality Control Supervisor

PRECISION LIFE SCIENCES

The Quality Control Supervisor will oversee, manage and provide direction to the QC department that will effectively meet or exceed the internal expectations by providing superior quality products and service. The Quality Control Supervisor will collaborate with Supplier Quality, Operations and Research and Product Development with assessing manufacturability and supporting design transfer activities. Excellent communications and analytical skills, strong technical project management skills and a Bachelors’ degree in Engineering will be essential for this position.

Main Duties & Responsibilities, Specific:

  • Leadership, training and mentoring
  • Manage Workforce Planning for the department assuring resourcing is adequate/appropriate for business demands.
  • Shape, sustain, and spread a continuous improvement culture through effective organizational change management
  • Must have exceptional organizational skills, ability to meet deadlines, thrive in a fast-paced environment and be able to problem solve effectively
  • Manages, builds and directs the efforts of the Quality Control Inspectors.

 

Skills, Duties and Responsibilities:

  • Provide strong leadership and motivating skills
  • Possess strong verbal and written communication skills
  • Excellent interpersonal skills within a diverse team environment
  • Demonstrates problem solving skills
  • Demonstrates analytical skills
  • Excellent organizational skills
  • Ability to prioritize, structure and schedule tasks to maximize effort and meet deadlines
  • Coordinate Quality Control activities to support Operation priorities
  • Quarantines, documents and evaluates products and materials
  • Trains personnel in these instructions and other technical process controls
  • Work closely with Quality Assurance, Regulatory Affairs, Supplier Quality and Operations / Logistics to ensure coordination and integration of QC activities with these departments.
  • Analyze the inspection activities and perform data trending for annual product review reports.
  • In collaboration with Supplier Quality Assurance, responsible for obtaining corrective actions from Vendors in relation to incoming article nonconformance in accordance with established procedures and SOPs
  • Responsible for the review and approval of inspection SOPs and quality system documents that pertain to the Quality Control function.
  • Manufacturing support
  • Maintain Equipment Number (EN) log and calibration system
  • Support Material Review Board (MRB) activities
  • Inspect and release all components (including piece parts, sub-assemblies and finished goods)
  • Responsible for assuring the integrity and completeness of Device History Files
  • Responsible for staffing, positioning, hiring and disciplinary action (as necessary) the QC department
  • Responsible for maintaining and equipping the inspection department to meet the needs of tests and inspections required by new and modified products
  • Responsible for assuring First Article Inspections are completed for all new/modified articles
  • Responsible for assuring QC Inspectors are properly trained in all inspection equipment and techniques, procedures and SOPs
  • Responsible for maintaining efficient work flow, work assignments and throughput standards for incoming articles
  • Responsible for defining, establishing, and implementing raw material, in-process, and finished quality sampling and inspection plans to include the use of statistical quality/process control where applicable

    Education and Experience:

  • Bachelor’s degree in engineering or equivalent experience.
  • 5+ years of experience in Biotechnology or Medical Device industries
  • Experience with medical device quality management systems: ISO 13485:2016, FDA 21 CRF Part 820
  • Excellent written and oral communication skills and interpersonal skills in the business environment
  • Well-developed sense of discretion, tact and diplomacy
  • Proficient in navigating computer systems including Excel, Word and PowerPoint
  • Proficient using eQMS systems, such as Master Control
  • Experience reading, interpreting and inspecting to engineering drawing.

 

Reporting Structure / Office Requirements

  • Reports to the Sr. Director, RA/QA
  • 4-8 direct reports (single shift)
  • On-Site required
  • First Shift, Monday – Friday
  • Location: West Chester, PA
  • Reports to: Sr. Director, Quality & Regulatory

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Posted On: Monday, November 28, 2022



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