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.
Summary of Position with General Responsibilities
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.
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.
Education and/or Experience
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.
Internal Number: 2018-12005
About Becton Dickinson
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help improve patient outcomes, improve the safety and efficiency of clinicians’ care delivery process, enable laboratory scientists to better diagnose disease and advance researchers’ capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. In 2017, BD welcomed C. R. Bard and its products into the BD family. For more information on BD, please visit bd.com.