Quality Systems Leader

BD; San Diego (CA); On-site; USD 124,000 - 206,000; Full time

Job summary

BD is seeking a Quality Systems Leader to oversee the Quality Management Systems for the IPD Design Center. This role involves leading compliance efforts, managing audits, and driving quality system initiatives across teams to align with regulatory standards. Ideal candidates will have a strong background in quality systems within the medical device industry and contribute to ongoing improvement efforts in a fast-paced environment.

Qualifications

• Bachelor's degree preferred.
• Experience in regulated industry.
• Knowledge of ISO 14971, GxP, FDA cGMP.

Responsibilities

• Lead cross-functional QMS improvement projects.
• Support audits and regulatory inspections.
• Manage complaint handling and trending activities.

Skills

Communication

Problem Solving

Organizational Skills

Interpersonal Skills

Education

Bachelor's degree in Engineering or Science

Job description

Join to apply for the Quality Systems Leader role at BD

Join to apply for the Quality Systems Leader role at BD

Get AI-powered advice on this job and more exclusive features.

Job Description Summary

Reporting to the Senior Manager of Design Controls and the Quality Systems Excellence Manager the Leader provides leadership to the IPD Design Center Quality Management Systems organization and develops and implements robust, compliant processes. This role leads implementation of QMS strategy, and assures alignment of tactics, to achieve the BD-wide Inspire Quality (IQ) initiative’s objectives for quality process integration and ongoing maintenance of an integrated QMS across Infusion Preparation and Delivery [IPD].

Job Description Summary

Reporting to the Senior Manager of Design Controls and the Quality Systems Excellence Manager the Leader provides leadership to the IPD Design Center Quality Management Systems organization and develops and implements robust, compliant processes. This role leads implementation of QMS strategy, and assures alignment of tactics, to achieve the BD-wide Inspire Quality (IQ) initiative’s objectives for quality process integration and ongoing maintenance of an integrated QMS across Infusion Preparation and Delivery [IPD].

Through outstanding communication, effective problem solving and active management of ambiguous situations, the Quality Systems Leader ensures process effectiveness and compliance with relevant procedures and regulations across IPD sites and locations as needed. The incumbent will collaborate across functionally to ensure successful implementation and maintenance of business and compliance processes throughout the IPD Division. This position is expected to evolve and support a Continuous Improvement focus on overall QMS.

The Quality Systems Leader will be expected to lead the activities related to QMS optimization and inspection/audit readiness.

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.

About The Role

As part of the Quality team within the Medical Pharmaceutical Systems (MPS) business unit, this position will support the MPS Quality Management System (QMS) by leading quality systems projects/initiatives; managing external regulatory inspections and related activities; and supporting MPS sites through external audits and regulatory submissions. This role will provide technical guidance on quality system requirements and facilitate training sessions as needed.

Responsibilities Include But Are Not Limited To

• Lead cross-functional QMS improvement projects, including development of project plans and documentation, establishing timelines, and tracking progress.
• Support internal and external audits and assessments, such as annual management reviews, corrective action investigations, and compliance audits.
• Prepare and lead external regulatory inspections, working closely with site personnel to ensure compliance with regulations and effective communication during the inspection process.
• Manage complaint handling and trending activities.
• Coordinate and track corrective actions associated with nonconformances identified through audits or other means.
• Assist with development and maintenance of Standard Operating Procedures (SOPs), Formaldehyde Release (FR) risk assessments, and other required documentation.
• Train personnel on quality systems topics and ensure adequacy of records and documentation.
• Participate in new product development activities and ensure appropriate quality system controls are implemented.
• Provide input to quality metrics and reporting for the Business Unit and Corporate.
• Other duties as assigned.
  
  

Minimum Requirements

• Bachelor's degree in Engineering, Science, or equivalent experience preferred.
• Experience in quality systems within a regulated industry, preferably medical device, pharmaceutical, or biotechnology.
• Knowledgeable in quality system standards and regulatory requirements, including ISO 14971, GxP, FDA cGMP, and EU Annex 11.
• Excellent written and verbal communication skills.
• Strong organizational and interpersonal skills.
• Ability to work independently and collaboratively in a fast-paced, dynamic environment.
  
  

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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 visithttps://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.

Required Skills

Optional Skills

Primary Work Location

USA CA – Brea

Additional Locations

USA CA - San Diego TC Bldg C&D

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 or hourly rate 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 or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information

$124,700.00 - $205,800.00 USD Annual

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Biotechnology Research, Medical Equipment Manufacturing, and Research Services

Referrals increase your chances of interviewing at BD by 2x

Get notified about new Quality Lead jobs in San Diego, CA.

Sr. Clinical Quality Assurance Manager - San Diego/Hybrid

Senior Quality Engineer - Risk Management (Remote)

Senior Supervisor, Quality Control - Incoming Mechanical Inspection

National City, CA $28.00-$36.00 4 months ago

Senior Staff Quality Engineer (Strong Medical Device Exp) Onsite

Staff Image Quality Evaluation Engineer, Silicon

Associate Director, Operational Excellence

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.