BD (Becton, Dickinson and Company) Quality Manager in Woburn, Massachusetts

BD Interventional’s Surgery worldwide business unit, located in Rhode Island, is a leading developer, manufacturer, and marketer of innovative, life-enhancing medical technologies. For the past 40 years, we have stood out as the market leader in providing solutions in soft tissue reconstruction including products for hernia repair, specialized surgical procedures, fixation and biologic implants. In addition to this extensive suite of products, our BioSurgery business is delivering a growing line of enhanced sealants and hemostatic products to complement surgical techniques across, thoracic, cardiovascular and other surgical specialties.

Our company has a strong tradition of developing our employees to learn, grow and excel. We are continually building our team with qualified, team oriented individuals to enhance the success of our company.

BDI Surgery's Woburn, Massachusetts manufacturing facility manufactures hemostasis products, hernia and abdominal wall repair products. The facility also manufactures biological odor eliminators and creams/gels for BDI Interventional's Urology & Critical Care business unit, which is used primarily in hospitals and nursing homes.

Responsible for the general management of the Woburn Operations Quality Assurance function to assure compliance to established standards of corporate objectives and regulated agencies for industry (ISO and FDA). Responsible for the planning, development, and implementation of quality systems that support the Woburn Ops and Davol business objectives and resources. Appointed ISO management representative and JPAL Engineering Manager for management team.

  • Develops operational Quality strategy as a business partner to optimize the performance of plant and compliance.

  • Evaluates plant’s QA/QC capability, identifies gaps, and recommends issue resolution to senior management.

  • Ensures the implementation of the operational Quality strategy.

  • Provides leadership in interpretation, teaching, and gains commitment and ownership of Quality initiatives.

  • Support the facility as a Quality Management System (QMS) Representative.

  • Develop operational strategies to maintain a level of inspection readiness.

  • Development, implementation, and maintenance of quality systems to assure FDA, ISO, and JPAL compliance.

  • Optimize quality systems to effectively identify measure and reduce cost of quality activities.

  • Identify, support, and develop departmental resources to achieve business and quality objectives.

  • Coordinate all facility audits (FDA, ISO, JPAL, Corporate, OEM customer).

  • Review and approve Engineering changes to product; processes and materials.

  • To promote and support multi-discipline teamwork, i.e., activities that support the Woburn/Surgery management system inclusive of strategic initiatives and tactical plan.

  • Coordinate management review periodically to assess quality system.

  • Special projects as assigned.

  • Sound regulatory, technical, and business knowledge

  • Sound decision-making with minimal information

  • Thorough understanding of QA/QC systems and manufacturing processes.

  • Strong working knowledge of GMP and ISO requirements.

  • Strong working knowledge of statistical quality tools.

  • Strong oral and written communication skills.

  • Strong working knowledge of applications related to SPC, Process Validation, FMEA, Part Qualification, and equipment qualification.

  • Bachelor’s degree in Engineering or Technical Sciences. Master’s degree in Engineering or Technical Sciences preferred.

  • Minimum of ten years’ experience in a federally regulated industry to include Quality Assurance and/or Regulatory Affairs.

  • Minimum five years supervisory experience.

  • National Certification in CQE, CRE, CQA or CQM.

Occasionally requires light physical effort as in periods of prolonged standing, sitting at files or work tables or bending, stooping or reaching and/or occasional lifting of light items (i.e. up to 30 lbs.).

May require some exposure to chemicals used in manufacturing processes.

ID: 2018-12005

Relocation Available?: No

External Company Name: C.R. Bard, Inc.

External Company URL: www.crbard.com

Street: 160 New Boston Street

C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.

We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.

Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.