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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 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. Possess in-depth knowledge of Good Manufacturing Practices (GMP) and Quality Engineering Principals to site’s Operations team. This role will also provide support during the design transfer or design change.
People Management:
1. Mentors and develops team members, including succession planning.
2. 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.
3. Motivates and develops junior staff
4. Acts as advisor and coach to subordinates to meet schedules and resolve technical problems.
5. Ensures effective conflict resolution among team members to maintain team’s cohesiveness while ensuring alignment of team to business goals.
6. Develops and administers work schedules and provides management with updates on work assignment, quality metrics, and or quality issues.
7. Identifies and works through obstacles that may hinder associates from focusing on and delivering their individual impact goals.
8. Ensures the functional quality organization fulfills its obligations and complies with applicable regulations and procedures.
9. Effectively navigates and leads through the challenges of change and establish key stakeholder engagement focused on win-win solutions.
10. Continuously evaluate progress toward tactical goals and objectives adapting them to meet customer and business needs
11. Manages customer impacting issues; prioritizing quality and compliance minded solutions that uphold the company and its standards.
12. Maintains positive and cooperative communication and collaboration with all levels of employees, customer, contractors, and vendors.
Functional responsibilities:
1. 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.
2. Leads the Product Realization – Control of Nonconforming Products and Material Review Board process
3. Effective use root cause analysis, application of technical principles, quality tools, and quality systems.
4. Uses process and quality control statistical methods to identify and correct or support the continuous improvement of QMS and production processes
5. Gather, evaluate, analyze, and present quality metric results (i.e.: Quality Notification, Targeted QN trending, Total NC trending) to identify leading indicators of issues.
6. Drive quality improvements to address these leading indicators, complaints, nonconformances, CAPA. Collaborates and works with a cross-functional matrix environment to implement continuous improvements.
7. Follow 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 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 judgement to influence within and across functions to drive impact on the business/function.
Must have working knowledge/specialization
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 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.
Required Skills
Optional Skills
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Primary Work LocationUSA CA - San Diego (BDB)Additional LocationsWork ShiftAt 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
$124,100.00 - $204,800.00 USD Annual