Manager Quality Engineering

Manager Quality Engineering

The Manager Quality Engineering is responsible for the management, direction and coordination of all quality and regulatory compliance activities across the designated Columbus Manufacturing BU in compliance with world-wide regulations, business strategies, and customer needs. This includes providing the quality leadership encompassing Quality Systems, Quality Engineering, and Sterilization control to ensure that the required production, quality and regulatory standards are achieved through molding, assembly, packaging, sterilization and product release. Reports to the site Associate Director Quality Management with dotted line reporting to the designated BU Manager.

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 usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto 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.

Essential functions include, but are not limited to, the following:

• Manages and leads the Quality Systems and Quality Engineering activities for the designated BU.
• Manages and support validation activities related to processes, products, materials and projects supporting the designated BU and other BUs when requested.
• Develops and implements strategic direction for the designated BU consistent with Hypodermic Platform, MDS and BDX Quality strategy.
• Provides effective Quality Management leadership to designated BU BLT and contributes to the Columbus Quality leadership Team in order to meet quality, business and organizational objectives of the BD Medical: Medication Delivery Solutions.
• Provides effective leadership in teamwork development, effective communication and quick responses to customers. Drives improvements towards customer centricity.
• Implements effective CAPA process focused on reduction of causes of customer complaints, non-conformances, excursions, rejections and waste.
• Assesses and builds organizational capability for Quality management, particularly in the selection and mentoring of dedicated high caliber QEs and QC Reps (Quality Engineering and Quality Representatives) professionals.
• Evaluates, facilitates, designs, implements and continually improves quality systems and business processes, including product controls to achieve quality goals and to maintain a high level of regulatory compliance.
• Management representative for the designated BU with regards to all Quality System regulation issues.
• Enhances BD Columbus designated BU managements understanding and application of broad scope Quality Management principles through education, training, and workshops.
• Provides leadership and guidance in integrating Quality Management and continuous improvement into the Columbus business strategic planning process.
• Champions the needs of both internal & external customers by factoring these needs into planning & decisions at all levels.
• Builds a strong interactive working and strategic relationship with appropriate designated Platform Quality, R&D and Regulatory management groups.
• Builds & sustains a Columbus business culture that accepts Excellence as an expectation, compliance as an outcome and goal.
• Provides coaching, and facilitation support to all levels at the designated BU Columbus plant.
• Interfaces with Regulatory Agencies (FDA, ISO notified body, other foreign regulatory bodies).
• Leads and supports customer audits, internal audits.
• Recommends and implements necessary actions and programs to continually upgrade the Quality Management/Quality System/Quality Engineering capability of the designated BU.
• Engage and deploy zero customer complaints program.
• Support the designated BU to meet: CPM, Financial goals, Waste target, CI projects, Deliveries, Zero past due CAPA, BBQ, 5S.
• Other duties, as assigned.

Requirements:

• Bachelor of Science degree in Engineering or Science related field.
• Minimum 5 years' experience in quality, with a minimum of 3 years in the medical device industry
• Experience with Validations, CAPA, Statistical Analysis.
• Experience with high volume manufacturing processes.
• Experience in Lean/Six Sigma.
• Experience managing and leading people.
• Experience communicating with all levels of the organization.
• Capable to manage under pressure and set priorities accordingly.
• Full support to a 24/7 operation.

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.

BD is committed to providing a robust set of value-based programs and resources that are best-in-class, market-competitive and affordable for all associates and their families.

• Competitive pay
  Access a portion of your pay before pay day with DailyPay
• Healthcare coverage: No paycheck contributions for eligible associates under a certain salary threshold enrolled in the HSA Basic Medical Plan option, no matter how many dependents you cover.
  Preventive care covered at 100%.
  Dental and vision insurance at group rates.
• Paid parental leave up to 6 weeks
• Adoption assistance plan
• 401(k) plan with 75 cents on the dollar matched by BD up to 6% of compensation
• Company paid basic life and AD&D insurance
• Tuition reimbursement
• Discounted home, auto and pet insurance
• Paid holidays and vacation (pro-rated the first year based on actual start date)

All benefits and policies are subject to eligibility and enrollment requirements. Most coverage begins on your first day or the date you become eligible for benefits.

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.

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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