BD (Becton, Dickinson and Company) Associate Director, Quality Management in Franklin Lakes, New Jersey
Job Description SummaryThe Associate Director, Quality Management reports to the VP Quality Management. The Associate Director, Quality Management is responsible for developing and executing the Diabetes Care Quality strategy in collaboration with the Diabetes Care Quality VP Quality Management. The Associate Director, Quality Management ensures that design change projects have appropriate Quality Engineering support.
The individual is responsible for overseeing product Quality performance and identifying appropriate actions required to remediate Quality and Safety concerns as well as drive continuous improvement to products in the Post Market lifecycle, including complaint handling and management. The position also has the authority to assure that all products are designed and manufactured utilizing systems which comply with current Industry, Government and BD Standards and conform to customer expectations for Safety and Effectiveness.
Assume a leadership role in continuous improvement of current products and practices to improve quality, patient experience, and worldwide market share.
Develop the Unit Quality Engineering strategy in collaboration with the VP Quality Management.
Execute, Measure and Report on the progress of the Quality Engineering Strategic initiatives.
Effectively partner with R&D, Operations, Regulatory, Medical Affairs, Marketing, and manufacturing plant quality & engineering teams.
Participate in and provide technical support to the Customer Facing activities.
Monitor product performance and execute CAPA activities as needed to address and/or prevent non-conformances.
Lead/manage the Designated Complaint Handling Unit (DCHU) group responsible for BDDC complaint handling.
Responsible for delivering key elements of the Management Review and Post Market Surveillance Meetings (Product Performance Issues).
Assure Division wide policies, procedures and systems are designed and implemented to produce products which conform to established quality standards and comply with Industry and Government Standards.
Support manufacturing sites with appropriate technological and problem solving skills and resources to prevent and or minimize adverse situations.
Develop and continuously improve skills and adequacy of department resources in order to maintain appropriate levels of Quality Engineering.
Provide the required Quality Engineering support to the continuous improvement and business cost reduction efforts linked to operational effectiveness.
Maintain a constant level of current technology within the Quality Engineering function and share this technology with the entire organization.
Continuously apprise Senior Management of the level of quality and patient risk throughout the Division.
Prepare, maintain, and adhere to approved departmental budget as needed.
Experience and Education:
B.S. degree, in a scientific, technical or engineering discipline. Master in business or scientific discipline preferred.
ASQ Certified Quality Engineer, Six Sigma Black Belt or equivalent experience (preferred).
A minimum of eight (8) years progressive experience in Quality within an FDA-regulated industry.
Expert in Design Controls
Knowledge, Skills and Abilities:
Extensive knowledge of applicable regulatory requirements.
Training in design of experiments and statistics. Class II / III medical device experience. Knowledge of six sigma methodology preferred. Knowledge of design control principles (preferred). Ability to support internal / external audits.
Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, and ISO 13485 / ISO 14971
Knowledge and experience in manufacturing, project management and engineering.
Must possess excellent oral and written communication skills, and proven supervisory/leadership capability.
Management and development of Quality professional and technical staff.
Provide technical product direction and coordination to all Plant Quality.
Demonstrated ability to understand and communicate complex technical, statistical and compliance subject matter
Ability to manage and prioritize multiple activities with varying business, compliance and customer drivers.
Expertise in regulations affecting medical devices marketed in all regions throughout the world.
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.
Primary Work LocationUSA NJ - Franklin Lakes
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