Quality Engineering Manager

Regulatory Jobs; San Diego (CA); On-site; USD 132,000 - 211,000; Full time

Job summary

BD is seeking a Manager of Quality Engineering to lead the Quality Management strategy at the WWISD Design Center, aligning with ISD Quality Leadership. The role provides quality engineering leadership, oversight, and direction to sustain a compliant QMS and support new product development and maintenance of medical devices.

The position requires expert knowledge of 21 CFR 820 and ISO 13485, expertise in risk management per ISO 14971, and the ability to lead a team of QA professionals in a

Qualifications

• 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 21 CFR 820, ISO 13485, ISO14971 and ISO 10993.
• Strong understanding of design quality assurance.
• Knowledge of DFSS, Six Sigma Green Belt or Black Belt desirable.
• Experience in applying Quality Engineering tools, statistics and problem-solving methodologies.

Responsibilities

• 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.

Skills

Quality engineering leadership

Regulatory knowledge

Design Controls

Risk Management

Statistical Analysis

Project management

Leadership

Education

Bachelor’s degree in Engineering or related discipline

Tools

DFSS

Six Sigma

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,sustenanceand 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 tomaintainquality 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, ISO14971and ISO 10993.
• Strong understanding of design quality assurance.
• Manufacturing and project management experience is desirable.
• Knowledge of DFSS, Six Sigma Green Belt or Black Beltare desirable. Excellent communication, technicalwritingand leadership skills.
• Experience in applying Quality Engineering tools,statisticsand 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.

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

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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