Manager Quality Engineering

bdx; Columbus (NE); On-site; USD 110,000 - 170,000; Full time

Job summary

BD seeks a senior Quality leader to manage Quality Systems and Quality Engineering for the Columbus BU. You will drive validation activities, CAPA, and continuous improvement while guiding a cross-functional team to meet BD Medical: Medication Delivery Solutions quality objectives.

You will oversee regulatory compliance, lead audits, and champion customer-centric quality improvements in a 24/7 operation environment.

Qualifications

• BS in engineering or science; minimum 5 years in quality with 3+ years in medical device industry.
• Experience with validations, CAPA and statistical analysis.
• Experience with high-volume manufacturing processes.
• Experience in Lean/Six Sigma.
• Proven ability to manage and lead people; strong communication under pressure.

Responsibilities

• Leads the Quality Systems and Quality Engineering activities for the designated BU.
• Supports validation activities for processes, products, materials and projects.
• Implements strategic direction for QA aligned with BD Quality strategy.
• Provides leadership to BU BLT and Columbus Quality leadership team.
• Drives continuous improvements and customer-centric quality improvements.
• Oversees CAPA program to reduce customer complaints and waste.
• Interfaces with regulatory bodies and leads internal/external audits.

Skills

Quality Management

Leadership

Communication

Problem Solving

Lean Six Sigma

Education

Bachelor of Science in Engineering or Science

Tools

Validations

CAPA

Statistical Analysis

Job description

We are the people who give possibilities purpose

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.

Job Description

ESSENTIAL FUNCTIONS (RESPONSIBILITIES)

Essential functionsinclude, 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 management’ s 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.

Why Join Us?

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.

Required Skills

Optional Skills

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Primary Work Location

USA NE - Columbus (West)

Additional Locations

Work Shift