Summary of Position with General Responsibilities:
Coordinates and performs Quality Assurance functions to support Manufacturing Areas as well as Supplier Quality, as assigned. Takes a leadership role in driving Quality Assurance and Quality Improvement.
Essential Job Functions:
- Evaluate Quality issues and drives corrective action.
- Evaluate customer complaints and drives corrective action.
- With the Supplier Quality function, act as liaison to suppliers relative to Quality issues and corrective actions.
- Use failure investigation tools to investigate causes of Customer, Manufacturing, and Supplier Quality issues. Take the lead with other functional groups in resolving these issues.
- Lead Quality Improvement projects.
- Serve as Quality representative on Material Review Board. Take the lead in driving corrective action from MRB.
- Serve as Quality representative for technology transfers, cost improvement projects, etc.
- Interface with other functional areas as required for writing specifications, preparing protocols and reports, implementing changes, completing process validation requirements, etc.
- Develop appropriate test and inspection procedures and sample plans to ensure the highest possible quality at a reasonable cost.
- Develop, validate, and modify test methods and appropriate inspection procedures and protocols.
- Review and approve changes to procedures and specifications.
- Track and respond to quality trends.
- Apply risk-based, statistical, or sound engineering judgment when making quality decisions.
- May assist with audits as needed.
- May support Supplier Quality Team as needed.
- Other duties as required.
- Customer/quality focused
- Business results-aligned
- Technically competent
- Ethical behavior
- Good communicator
- Idea generator
- Change agent
- Decision maker
- Bachelor’s degree in Engineering or Applied Sciences.
- Minimum four years experience in Quality in the medical device industry or other regulated industry.
Occasionally requires light physical effort as in periods of prolonged standing, sitting at files or work tables, or bending, stooping, or reaching, and/or occasional lifting of light items (i.e. up to 30 lbs). May require some exposure to chemicals used in manufacturing processes.
Some minor physical inconvenience or discomfort occasionally present in the work environment (moderate noise, disagreeable odors, etc.). Occasional exposure to potential for minor injury or other health hazard requiring some precaution.
On-the-job, SOPs required for position and GMP.
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.
Primary Work Location USA NY - Glens Falls