Operations Quality Assurance Manager

1 week ago

Durham, United States BD Full time
Job Description Summary This position is accountable to ensure that Parata site’s procedures and practices are compliant with BD standards and applicable US & global regulatory requirements. This position is accountable to provide leadership, development and coaching for the site’s quality operations team.
This position partners with the R&D, design assurance, global operations and manufacturing, service repair, customer service and sales/marketing organizations to provide guidance as it relates to the implementation of the quality system and to ensure compliance to product, customer, and regulatory expectations.
Through outstanding communication, effective problem solving and active management of ambiguous & complex situations, the primary deliverables for the role are to ensure capable processes are implemented and maintained at the Parata manufacturing areas through proper process validations where applicable and ongoing inspection & testing in compliance with the product requirements, Quality System, and applicable US & global regulatory requirements. This position interacts directly with NRTL (Nationally Recognized Testing Laboratory) for all issues related to manufacturing where applicable.
The following Parata roles report to this position: Incoming Inspection, Quality Control, Metrology and Quality Engineering.
This position contributes to WW functional strategy and priorities and ensures effective deployment within the plant. Equally, the Manager, Quality Assurance is expected to promote the creation of a culture of Quality throughout the plant.

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’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.

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.


Primary Responsibilities

  • Responsible for developing and maintaining plant strategic quality and compliance plans and policies.
  • Accountable for the effective execution of processes carried out under departmental leaders (Quality Engineering, Incoming Inspection, Metrology, Quality Control), by prioritizing and leading people, resources, and budget to accomplish expected requirements and performance.
  • Engage and provide leadership directions/objectives, coaching and personal development of site’s Quality associates to perform to their best ability and meet both personal and plant objectives.
  • Define framework for team objectives, operation schedule, processes, and budgets in line with department and BU priorities.
  • Act as the plant quality management representative for tier meetings ensuring compliance issue resolution.
  • Build an influential and effective network and communication with plant leadership team members in driving overall plant performance relying on a strong culture of Quality and Continuous Improvement.
  • Accountable to successfully lead and communicate quality issues.
  • Accountable for identifying quality improvement opportunities within operations and partnering with peers in Manufacturing & Operations and from other sites where applicable to develop and implement solutions – evaluate, propose and implement new processes and technologies as alternatives to optimize efficiencies in the departments.
  • Ensure that site quality team is staffed, organized, and resourced to ensure it can fulfill its obligations to comply with US & global regulatory requirements and BD procedures.
  • Develop a cohesive team, maintaining and reinforcing a strong quality presence in the manufacturing areas, encouraging positive relationships and networking effectively across sites and organizations.
  • Handle performance issues and solicit the appropriate input from HR, partners and management – write and administer performance appraisals on time and in a thorough and thoughtful manner.
  • Direct overall operational leadership in planning and management of quality systems activities, including resource management, which can include the following: Validation/Qualification program Internal and external compliance / quality audits Non-conforming material Corrective and preventive action program GMP training program Quality engineering Process and Product Change Control Document Control Customer feedback i.e. Installation Failure report and Complaint management
  • Implement corporate Quality policies ensuring finished products conform to company standards and satisfy GMP regulations.
  • Other duties as assigned.

Minimum Educational Experience:

  • Educated to Bachelor Degree or equivalent in appropriate subject; Master Degree preferred.
  • 10 years+ experience in Automotive, Aerospace, Large Scale Robotics manufacturing.
  • 8 years+ experience in plant Quality or Quality Operations.
  • Must be familiar with ISO9001 and having lead/participated in related audits & inspections
  • Experience in either production or engineering management.

Desirable Qualifications:

  • Production or engineering management preferred.
  • Six sigma knowledge and or certification of green or black belt preferred.
  • Multi-country/multi-cultural experience preferred

Required Skills and Knowledge:

  • Strong negotiating, influence, and leadership abilities
  • Strong analytical & problem-solving skills
  • Ability to build and maintain a team and to work in a matrix organization
  • Ability to align his organizational strategy to the business and department’s vision and lead his team accordingly
  • Ability to effectively use Change Management models to mobilize the organization
  • Ability to define a project and lead teams through execution
  • Action oriented when facing issue, change and uncertainty
  • Ability to measure team’s performance using metrics and analytical indicators

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are critical 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 Location USA NC - Durham - Roche Drive

Additional Locations

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