Job Description SummaryThe Quality Manager Site Validation is responsible for execution and implementation of Corporate and Unit validation initiatives at the site. Additional responsibilities include developing and maintaining the Validation Master Plan, training and educating associates and developing a validation support structure and document handling system. The Quality Manager Site Validation is also responsible for the calibration and metrology department. Job Description ESSENTIAL FUNCTIONS (RESPONSIBILITIES)
- The essential functions of this position include but are not limited to:
- Local implementation of Validation Toolkit
- Publish site specific progress reports
- Develop and maintain Validation Master Plan (VMP)
- Develop and maintain Validation Tracking Schedule (VTS)
- Ensure validation support structure and document handling system are developed and maintained
- Provide training and educational sessions appropriate for associates relevant to validation procedures.
- Establish and maintain systems that track training and training records
- Establish and maintain systems that track Validation records; i.e. protocols, completion reports, and total Validation Package
- Establish mentoring process to improve effectiveness of validation work
- Communicate site activities regarding validation
- Develop and maintain validation procedures and related local records
- Maintain records of plant studies and MSA's
- Approve validation protocols and related reports as needed
- Develop and maintain metrics to measure progress
- Work with Corporate Validation Services to sustain validation activities
- Support Regulatory Audits, inspections and Internal audit Plan.
- Support site change control procedures
- Participate in Management Review to report on validation status
- Develops and maintains the plant FMEA system
- Quality Assurance (QA)
- responsible for small team
- B.S. or B.A. Degree in Science or Engineering field is required.
- Minimum 5 years' experience in quality, with a minimum of 3 years in the medical device industry
- Experience managing and leading people.
- Experience communicating with all levels of the organization.
- Capable to manage under pressure and set priorities accordingly.
- Full support to a 24/7 operation.
- Experience in Quality Assurance and/or Mathematics/Statistics could be used in lieu of education in Science or Engineering.
- Process validation training Six Sigma or CQE certification (Green Belt Level) - desired
- Working knowledge of statistical tools such as control limits, statistical process control, probability and trending, FMEA, and Measurement System Analysis.
- Working knowledge of the Federal Regulations and International Standards pertaining to Medical Devices, and their application.
- Experience with Validations, CAPA, Statistical Analysis, Change Control.
- Experience with high volume manufacturing processes.
- Manages the Calibration department to ensure 100% compliance and performance.
- Supports plant Safety initiatives
- Managerial duties may be assigned based on business need or individual competencies.
- Interfaces with Regulatory Agencies (FDA, ISO Registrar body, other foreign regulatory bodies).
- Leads and supports customer audits, internal audits.
- Recommends and implements necessary actions and programs to continually upgrade the Quality Management/Quality System/Quality Engineering capability.
- Engage and deploy zero customer complaints program.
- Other duties, as assigned.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status. #LI-OPS
Primary Work LocationUSA NE - Columbus (West) Additional Locations Work Shift
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.