Sr Engr, Supplier Quality
Becton, Dickinson and Company (BD)
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Descrizione del lavoro
BD in Irvine, CA is seeking a Senior Supplier Quality professional to own the Supplier Quality Management System, drive governance, and ensure compliance with FDA/ISO requirements across supplier networks.
You will lead audits, CAPA, risk management, and continuous improvement initiatives using Lean Six Sigma methods, partnering with Procurement, Regulatory, and Quality teams to raise process maturity and supplier performance.
Competenze
- Bachelor's Degree in Engineering or related technical field.
- Minimum 5 years of experience in Supplier Quality, Quality Systems, Quality Engineering, Compliance, or related quality functions within the medical device, pharmaceutical, biotechnology, or regulated manufacturing industries.
- Experience developing, implementing, and maintaining Quality System procedures and processes.
- Experience with supplier controls, supplier auditing, risk management, change management, and CAPA systems.
- Experience working with electronic Quality Management Systems (eQMS), reporting systems, and data analytics tools preferred.
Mansioni
- Own, maintain, and improve Supplier Quality and Purchasing Control procedures, work instructions, forms, templates, and associated records.
- Lead harmonization and standardization of Supplier Quality processes across sites and business functions.
- Chair and facilitate Supplier Quality Review Board governance activities and action tracking.
- Lead change control activities related to Supplier Quality procedures and systems.
- Drive implementation and effectiveness monitoring of Supplier Quality process improvements.
- Maintain supplier qualification records, supplier compliance documentation, and approved supplier files.
- Manage Quality Agreement lifecycle activities, including execution, monitoring, renewal, and compliance tracking.
- Monitor supplier certifications and renewal requirements to ensure ongoing compliance.
- Ensure supplier quality records remain complete, accurate, traceable, and inspection ready.
- Identify opportunities for automation, digitization, and workflow optimization within Supplier Quality processes.
- Develop, maintain, and oversee the Supplier Audit Program and risk-based audit schedule.
- Support supplier risk classification and audit prioritization strategies.
- Ensure supplier audits are executed in accordance with established procedures and regulatory expectations.
- Monitor audit findings, corrective actions, and effectiveness verification activities.
- Provide supplier quality documentation and objective evidence during internal, corporate, customer, and regulatory audits.
- Maintain ongoing inspection readiness of Supplier Quality records and supporting documentation.
- Develop and maintain Supplier Quality metrics, dashboards, compliance indicators, and management review reports.
- Analyze supplier quality and system performance data to identify trends, risks, and improvement opportunities.
- Support Quality Data Reviews and Management Review processes.
- Develop meaningful KPIs to monitor Supplier Quality System effectiveness.
- Lead continuous improvement projects utilizing Lean, Six Sigma, or structured problem-solving methodologies.
- Drive preventive actions and systemic improvements to improve process efficiency and compliance.
- Serve as the Supplier Quality Systems subject matter expert for the organization.
- Provide guidance and training on Supplier Quality procedures, systems, and compliance requirements.
- Partner with Supplier Quality Engineering, Procurement, Manufacturing, Operations, Regulatory Affairs, and Quality Systems teams to ensure alignment and effective implementation of Supplier Quality processes.
- Support strategic initiatives involving supplier governance, business process improvement, and quality system transformation.
Conoscenze
Formazione
Strumenti
Descrizione del lavoro
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.
Apply advanced knowledge of quality systems, supplier controls, auditing, risk management, and continuous improvement methodologies to establish, maintain, and improve the Supplier Quality Management System. Ensure supplier quality processes remain compliant with applicable regulatory requirements, industry standards, and company procedures while driving system effectiveness, governance, and operational excellence.
- Own, maintain, and continuously improve Supplier Quality and Purchasing Control procedures, work instructions, forms, templates, and associated records.
- Ensure Supplier Quality processes remain compliant with applicable regulatory requirements, internal procedures, and Quality System requirements.
- Lead harmonization and standardization of Supplier Quality processes across sites and business functions.
- Chair and facilitate Supplier Quality Review Board governance activities and action tracking.
- Lead change control activities related to Supplier Quality procedures and systems.
- Drive implementation and effectiveness monitoring of Supplier Quality process improvements.
- Maintain supplier qualification records, supplier compliance documentation, and approved supplier files.
- Manage Quality Agreement lifecycle activities, including execution, monitoring, renewal, and compliance tracking.
- Monitor supplier certifications and renewal requirements to ensure ongoing compliance.
- Ensure supplier quality records remain complete, accurate, traceable, and inspection ready.
- Identify opportunities for automation, digitization, and workflow optimization within Supplier Quality processes.
- Develop, maintain, and oversee the Supplier Audit Program and risk-based audit schedule.
- Support supplier risk classification and audit prioritization strategies.
- Ensure supplier audits are executed in accordance with established procedures and regulatory expectations.
- Monitor audit findings, corrective actions, and effectiveness verification activities.
- Provide supplier quality documentation and objective evidence during internal, corporate, customer, and regulatory audits.
- Maintain ongoing inspection readiness of Supplier Quality records and supporting documentation.
- Develop and maintain Supplier Quality metrics, dashboards, compliance indicators, and management review reports.
- Analyze supplier quality and system performance data to identify trends, risks, and improvement opportunities.
- Support Quality Data Reviews and Management Review processes.
- Develop meaningful KPIs to monitor Supplier Quality System effectiveness.
- Lead continuous improvement projects utilizing Lean, Six Sigma, or structured problem-solving methodologies.
- Drive preventive actions and systemic improvements to improve process efficiency and compliance.
- Serve as the Supplier Quality Systems subject matter expert for the organization.
- Provide guidance and training on Supplier Quality procedures, systems, and compliance requirements.
- Partner with Supplier Quality Engineering, Procurement, Manufacturing, Operations, Regulatory Affairs, and Quality Systems teams to ensure alignment and effective implementation of Supplier Quality processes.
- Support strategic initiatives involving supplier governance, business process improvement, and quality system transformation.
- Support enterprise-wide Quality System initiatives as assigned.
- Perform other duties as required to support business objectives.
- Bachelor's Degree in Engineering or related technical field.
- Minimum 5 years of experience in Supplier Quality, Quality Systems, Quality Engineering, Compliance, or related quality functions within the medical device, pharmaceutical, biotechnology, or regulated manufacturing industries.
- Experience developing, implementing, and maintaining Quality System procedures and processes.
- Experience with supplier controls, supplier auditing, risk management, change management, and CAPA systems.
- Experience working with electronic Quality Management Systems (eQMS), reporting systems, and data analytics tools preferred.
- Demonstrated knowledge of Supplier Quality Systems, supplier controls, auditing programs, purchasing controls, quality agreements, and supplier governance processes.
- Working knowledge of applicable regulations and standards including FDA Quality System Regulations, ISO 13485, and risk management principles.
- Strong understanding of process validation, supplier qualification, supplier auditing, nonconforming material controls, CAPA systems, and continuous improvement methodologies.
- Strong analytical, organizational, problem-solving, and critical-thinking skills.
- Experience developing metrics, dashboards, reports, and management review inputs.
- Excellent written and verbal communication skills.
- Strong documentation and technical writing skills.
- Demonstrated ability to lead cross-functional initiatives and manage competing priorities.
- Ability to influence stakeholders and drive process improvements across multiple functions.
- Lean Six Sigma certification or equivalent continuous improvement experience preferred.
- Works independently with minimal supervision.
- Exercises sound judgment in evaluating compliance, quality system effectiveness, and process improvement opportunities.
- Makes recommendations and decisions based on risk analysis, regulatory requirements, and business needs.
- Leads cross-functional initiatives with significant organizational impact.
- Provides technical guidance and mentorship in Supplier Quality Systems and compliance matters.
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.
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.
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USA CA - Irvine Laguna Canyon
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.
- Health & Well-being: Medical, dental, vision, health savings and flexible spending accounts, life and disability insurance, wellness resources, mental health support, and disease management programs.
- Retirement & Financial Well-being: 401(k), deferred compensation programs, financial counseling, DailyPay, and educational savings resources.
- Work-Life Balance & Family Support: Paid time off, company holidays, educational assistance, parental leave, adoption assistance, backup care, caregiving support, employee assistance programs, commuter benefits, pet insurance, legal services, and associate discount programs.
- Leave Programs: Bereavement, military, personal, family and medical leave, and jury duty leave.
Additional details regarding benefits and well-being programs can be found in 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 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.
$105,500.00 - $168,800.00 USD Annual
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