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BD

Quality Engineering Manager

Location:  San Diego, USA
Location flexibility:  4 office days / week – Based on location and role requirements.
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Job Description

We are the people who give possibilities purpose

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.

Job Description

Job Summary:

The Manager, Quality Engineering supports the development and implementation of the Quality Management strategy for the WWISD Design Center in collaboration with ISD Quality Leadership. The role provides quality engineering leadership, oversight, and direction, sustains a compliant QMS, and supports new product development and product maintenance through application of quality engineering principles for medical devices.

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

  • Lead development, sustenance and continuous improvement of quality systems compliant with 21 CFR 820 and ISO 13485.
  • Execute, measure and report progress of Quality strategic initiatives.
  • Ensure policies, procedures and systems produce products meeting quality and regulatory requirements.
  • Provide Quality Engineering support and promote statistical tools in design and development activities.
  • Lead Risk Management activities in compliance with ISO 14971.
  • Support continuous improvement of quality and market competitiveness.
  • Develop department skills and resources to maintain quality assurance effectiveness.
  • Develop technical solutions to complex quality problems.
  • Lead a team of Quality Engineers at the design center.
  • Perform functional activities with minimal direction.
  • Provide leadership for multidisciplinary projects.
  • Serve as a site and functional Subject Matter Expert for Design Controls.

Education and Experience:

  • Bachelor’s degree in Engineering, Science or related discipline.
  • Minimum ten (10) years progressive experience in Quality Assurance within an FDA regulated industry.
  • Minimum 3 (three) years of direct management experience of QA professional and technical staff.
  • Extensive knowledge of applicable regulations and standards including 21 CFR 820, ISO 13485, ISO 14971 and ISO 10993.
  • Strong understanding of design quality assurance.
  • Manufacturing and project management experience is desirable.
  • Knowledge of DFSS, Six Sigma Green Belt or Black Belt are desirable. Excellent communication, technical writing and leadership skills.
  • Experience in applying Quality Engineering tools, statistics and problem-solving methodologies.

Knowledge and Skills:

Design Control Change Control Risk Management - ISO 14971 Process Validation, Design Verification & Design Validation Identification of CTQs Unit Quality Independent Reviewer During Design Reviews Handling of Deviations and Non-Conformances Test Method Validations Supplier Qualification Post Market Surveillance and Situation Analysis CAPA and Root Cause Investigation Statistical Analysis Strong strategic planning and prioritization skills Ability to lead and influence in a matrixed, global organization.

Why Join Us?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

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

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.

Required Skills

Optional Skills

.

Primary Work Location

USA CA - San Diego Bldg A&B

Additional Locations

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$131,600.00 - $210,500.00 USD Annual

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Working at BD

4 office days / week – Based on location and role requirements.

A little flex time – Based on role requirements.

Company benefits

Health insurance
__ days annual leave + bank holidays
Accrued annual leave
Company shutdown periods
Optional unpaid leave
Reservist leave
Buy or sell annual leave
Compassionate leave
Dental coverage
Fertility benefits
Hertility subscription
Mental health pathway
On-site wellness services
Complimentary Medical Services
Eye Care Support
Fertility treatment leave
Men’s health support
Mental health platform access
Personalised nutrition plan
Wellbeing allowance
Women’s health support
Critical Illness Insurance
Family health insurance
Gym membership
Menopause support
Mental health first aiders
Mental health support
Private GP service
Wellbeing incentive programme
Mentoring
Coaching
Learning platform
Further education support
Study support
Professional subscriptions
Collaboration spaces
Bike parking
On-site wellness room
Secure on-site parking
Cycle to work scheme
On-site barista
Private booths
Sensory-Friendly Setup
Chill out zone
Ergonomic workstations
Meditation space
On-site catering
On-site gym
On-site shower
On-site workout classes
Adoption leave
Eldercare services
Shared parental leave
Pregnancy loss leave
Summer holiday childcare
Carer’s leave
Emergency leave
Pregnancy support
401K
Annual pay rises
Equity packages
Salary advance
Additional voluntary pension contribution
Electric Car Salary Sacrifice
Income protection
Life assurance
Salary sacrifice
Nursery salary sacrifice scheme
Annual bonus
Enhanced pension match/contribution
Life insurance
Referral bonus
Share options
Theme park discounts
Cinema discounts
Coffee discounts
Restaurant discounts
Travel insurance
Employee recognition scheme
Career and family coaching
Death in service
Employee discounts
Sabbaticals
Sports teams
Workplace loan
Charity donation scheme
Company wide holidays/offsites
Financial advice
Relocation packages
Teambuilding days
Volunteer days
Car allowance
Company car
Employee assistance programme
Financial coaching
In house training
Neonatal leave
Physiotherapy
Will writing
Modern office
Enhanced maternity leave
Enhanced paternity leave
Tax-free childcare
Women’s health leave
Enhanced maternity leave
Women’s health leave
Non-contributory pension
Religious celebration leave
Bank holiday swaps
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Company employees:

60,000+

Office Locations