Quality Control Technician

Quality Control Technician primary functions assure sterilization operations meet the quality system requirements. Product is released to sterilization and shipping after review of documentation and assistance with core quality issues. The position provides training, guidance and input on quality issues to the sterilization floor, audits compliance with quality policy and procedures, and participates in continuous improvement and plant initiatives.

We are the makers of possible. BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

• Performs review of sterilization documentation
• Releases product to the next stage of shipping
• Follows up on sterilization process issues/findings with appropriate parties, supports investigation and suggests corrective actions.
• Initiates and/or responds to correction and preventive action reports. Documents quality system failures and improvement activities.
• Conducts routine product and process audits to assure compliance to the quality system.
• Performs complete inspection of product according to applicable specifications.
• Reports issues to the Supervisor Sterilization Assurance
• Responsible for internal documentation updates in SAP when applicable.
• Documents all inspections as required.
• Updates all reports and databases for reporting and tracking purposes.
• Possesses knowledge of Quality System Regulations and control charting defect trends in product quality.
• Ensures sterilization associates are properly trained in documented inspection techniques, methods, work instructions.
• Trends quality metrics and takes action to address problems and achieve departmental objectives.
• Attends, actively participates in, and successfully completes training sessions as needed and specified.
• Performs other duties as assigned (supporting site initiatives, internal or external audits, as part of audit team members).

• Supports and acts as Lead point person for audit and/or change control on Laboratory. Provides information in a timely manner, with relevant system evidence such as Master data export and direct screen sharing with auditors.
• Achieves safety, quality & manufacturing/sterilization shared goals through successful delivery of key business objectives and metrics.

• Participates fully to achieve the department’s safety goals.
• Maintains a clean and safe work environment.
• Takes responsibility for own safety.
• Holds self-accountable to follow all safety policies & procedures.
• Debriefs accidents & implements solutions to eliminate root cause.
• Offsets team members to safety standards/regulations & policies.

• High School diploma or GED plus 2 years of previous quality experience.
• May have additional certificates and/or bachelor’s degree in technology, engineering, business, or a closely related field.
• Experience with Quality SAP Everest.
• Computer
  
  Skills:
  
  Excel, Word.
• High degree of discipline and demonstrates attention to detail.
• Proven organizational skills and ability to plan & organize work efficiently.
• Good understanding of requirements, QSRs, GLPs, ISO, FDA Guidelines, as well as any other regulations.
• Strong verbal, communication and interpersonal skills are required: capacity to listen and understand users and stakeholder expectations.
• Must be able to work independently, but also work in a team environment, giving and receiving feedback.
• Demonstrates personal drive and accountability to meet deadlines per project plan.
• Demonstrates ability to solve problems, effectively manages risks and escalates as needed within established governance framework, strong sense of…