Quality Manager

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 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 find transformative solutions that turn dreams into possibilities.

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 Assurance Manager, Quality Engineering is accountable for sustaining and supporting all BDB San Diego reagents and assay manufacturing operations. Owns, tracks and reports on the non-conforming materials, deviation, Global Hold, and Material Review Board processes in accordance with the existing policy, procedures, and standards. Applies project management skills to lead cross-functional and interdepartmental investigations and ensures quality issues are closed with effective solutions. Possesses in-depth knowledge of Good Manufacturing Practices (GMP) and Quality Engineering Principles. This role also provides support during the design transfer or design change.

People Management:

• Mentors and develops team members, including succession planning.
• Focuses on employee engagement activities including development and retention, while also responsible for carrying out hiring, job assignments, termination recommendations, transfers, promotions, salary actions, and performance reviews on time.
• Motivates and develops junior staff.
• Acts as advisor and coach to subordinates to meet schedules and resolve technical problems.
• Ensures effective conflict resolution among team members to maintain team’s cohesiveness while ensuring alignment of team to business goals.
• Develops and administers work schedules and provides management with updates on work assignments, quality metrics, and/or quality issues.
• Identifies and works through obstacles that may hinder associates from focusing on and delivering their individual impact goals.
• Ensures the functional quality organization fulfills its obligations and complies with applicable regulations and procedures.
• Effectively navigates and leads through the challenges of change and establishes key stakeholder engagement focused on win-win solutions.
• Continuously evaluates progress toward tactical goals and objectives adapting them to meet customer and business needs.
• Manages customer impacting issues; prioritizing quality and compliance minded solutions that uphold the company and its standards.
• Maintains positive and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors.

Functional responsibilities:

• Oversees the Sustaining Quality Engineering team and process for BDB-San Diego and provides guidance to ensure that activities are performed in accordance with Quality Systems and Regulatory requirements. Ensure compliance to Quality System Requirement, such as ISO standards ISO 9001 and ISO 13485 requirements.
• Leads the Product Realization – Control of Nonconforming Products and Material Review Board process.
• Effective use of root cause analysis, application of technical principles, quality tools, and quality systems.
• Uses process and quality control statistical methods to identify and correct or support the continuous improvement of QMS and production processes.
• Gathers, evaluates, analyzes, and presents quality metric results (i.e.: Quality Notification, Targeted QN trending, Total NC trending) to identify leading indicators of issues.
• Drives quality improvements to address these leading indicators, complaints, nonconformances, CAPA. Collaborates and works with a cross-functional matrix environment to implement continuous improvements.
• Follows up to ensure results are translated into updates to Risk Management File documentation.

Requirements:

• Minimum of a B.S. in science, engineering, or other relevant discipline, with a minimum of 5 years relevant technical experience within medical, pharmaceutical, or Life Science industry.
• Minimum of 5 years’ experience in a people leading role.
• Knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. ISO 9001, ISO 13485).
• Able to contribute to long-range business strategies, choosing disciplines and methods appropriate to the work content and context. Can develop strategy, plan programs, and drive the completion of long-term goals and objectives.
• Can develop advanced quality methods and guide their application into development of a final product/process/business opportunity.
• Able to perform work without appreciable direction. Able to act independently on issue resolution, projects, and other assignments.
• Able to use judgment to influence within and across functions to drive impact on the business/function.
• Working knowledge of Six Sigma, statistical process control (SPC), process validation, and Lean manufacturing.
• Effective communication skills (written, verbal, and listening) are necessary.
• Previous experience with SAP and/or similar MRP/MRP II system is helpful.
• Ability to effectively work with peers, as well as manage up and down the organization.
• Effective prioritization skills, with special attention to detail, while maintaining overall perspectives.

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 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.