Job Description Summary

The Quality Manager is responsible for strategic oversight and leadership direction within the Production QA function to include: In-Coming Inspection of all raw materials, In-Process Inspection, Finished Goods Inspection, Final Product Release, Quality Engineering, Customer Complaint Investigation, Supplier Quality and Calibration/Metrology while maintaining full compliance with FDA Quality System Regulations (21 CFR Part 820), all applicable International Standards (i.e. ISO 13485, MHRA GMPs, etc.) and BD policies/procedures. This position will be the lead Quality representative for a class 3 legal manufacturing site.
Associate provides business, technical, and production support, as required; provides technical guidance to employees, as required; develops processes and procedures; has in-depth Quality Assurance expertise.

Job Description

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 MedTech 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. 

Summary

The Quality Manager is responsible for strategic oversight and leadership direction within the Production QA function to include In-Coming Inspection of all raw materials, In-Process Inspection, Finished Goods Inspection, Final Product Release, Quality Engineering, Customer Complaint Investigation, Supplier Quality and Calibration/Metrology while maintaining full compliance with FDA Quality System Regulations (21 CFR Part 820), all applicable International Standards (i.e. ISO 13485, MHRA GMPs, etc.) and BD policies/procedures.This position will be the lead Quality representative for a class 3 legal manufacturing site.
Associate provides business, technical, and production support, as required; provides technical guidance to employees, as required; develops processes and procedures; has in-depth Quality Assurance expertise.

Salary Range- $121,100 - $199,800

Duties and Responsibilities

• Effective implementation of the site QMS

• Responsible for strategic oversight and leadership direction of In-Coming Inspection, In-Process Inspection, Finished Goods Inspection, Final Product Release, Quality Engineering, Customer Complaint Investigation, Supplier Quality and Calibration/Metrology

• Knowledge of FDA regulatory requirements (QSRs – 21 CFR Part 820)

• Knowledge of International regulatory requirements (ISO 13845, MHRA GMPs, etc.)

• Responsible for Production and Process Controls from a Quality perspective

• Serves as a technical resource for all QA activities.

• Identifies data requirements, often beyond the standard, and collects all relevant data needed to analyze a complex problem, situation or issue.

• Advises others on a variety of topics within own functional area.

• Tracks internal trends and suggests process improvements based on observations.

• Leverages the appropriate resources to provide solutions for internal/external customers.

• Applies hypotheses and an understanding of cause and effect when analyzing a complex process, situation or issue or discerning data patterns.

• Identifies implications/conclusions from the logical analysis of a complex situation or issue.

• Serves as the QA subject matter expert (SME) and lead for internal/external regulatory compliance audits.

• Drives team to achieve established goals in proactive and pragmatic manner; adjusts plan of action accordingly to maneuver obstacles and achieve success.

• Manages budget for own area, allocates resources and delegates, accordingly, applying knowledge of profit drivers within own area / department.

Qualifications

• Bachelor of Science degree in an engineering or related field.

• Minimum 7 years' experience in quality, with at least 3-5 years in the medical device industry or Pharma.Understanding of Class 3 medical device standards and regulatory implications preferred

• Minimum 2-3 year's management experience

• Experience in interface with Domestic and Foreign government agencies.

• Experience with SAP JDE, Teamcenter and other quality platforms preferred.

• Experience in Lean/Six Sigma preferred.

• Computer proficiency in Microsoft Office (Word, Excel, Power Point, Project, and Outlook)

Physical Demands

• Must be able to lift, push/pull, and carry up to 25 pounds.

• Must be able to wear appropriate personal protective equipment as required.

• Position requires sitting or standing for long hours.

• Use of hands and fingers to manipulate office and calibration equipment is required.

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For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers

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. 

PDN

Primary Work Location

USA CA - Irvine Neomend

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture.  We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles.

Salary Range Information

$121,100.00 - $199,800.00