BD (Becton, Dickinson and Company) Senior Manager, Quality Systems in Franklin Lakes, New Jersey
Job Description SummaryThe Senior Manager, Quality Systems is directly responsible for managing the development, implementation, and improvement of the BD Medication Delivery Solutions (MDS), Diabetes Care (DC) and Preanalytical Systems (PAS) Franklin Lakes Unit Quality Management Systems. This position ensures that various Quality processes such as Internal Audits, Supplier Management, Corrective & Preventive Actions, Non-conformance Reports, Training, Analysis of Data, Design and Development, and Calibration are effectively implemented and comply with FDA Quality System Regulations, ISO 13485, MDD/IVD (MDR/IVDR), other MDSAP country regulations as well as any other applicable regulations/standards for Device products.
The Senior Manager, Quality Systems also supports the establishment and implementation of policies and procedures aimed at harmonizing the Quality Systems at BD Device sites worldwide and provides guidance and training. This position also establishes and implements process for collection and analysis of quality data from the BD Device sites. The Senior Manager, Quality Systems also support/represents the MDS/DC/PAS Businesses in the BD Quality Networks.
The summary below provides key responsibilities for the Senior Manager, Quality Systems:
Manages the various quality programs for the MDS/DC/PAS Franklin Lakes Units. These include CAPA, NCR, Internal Audits, Supplier Audits, Quality Certificates, Training, Calibration, Customer/Supplier Quality Agreements, Customer Complaints, Analysis of Data, Design & Development, etc.
Collaborates with cross functional partners such as Quality Engineering, R&D, Operations, Medical, Marketing to seek their input into the development of policies and procedures, and their support in addressing Quality Issues.
Manages the Internal/Supplier Audit program for the Device businesses. Ensures timely execution of planned audits, completion of corrective actions and closure of audits.
Hosts external regulatory inspections and audits. Ensures that pre and post-inspection activities are completed including scheduling, record review, training, logistics, etc. Prepares responses to audit nonconformities for review by senior management. Assists with FDA and external audit readiness at BD sites.
Ensures the CAPA Program is established and maintained.
Ensures that the training program is effectively implemented, and that appropriate training is assigned, provided and monitored to ensure Business training compliance goals are met.
Ensures that the NCRs and Specification Deviations are managed as per established processes and corrective actions are implemented in a timely manner.
Establish and maintain processes to analyze Quality Data from MDS/DC/PAS Sites.
Assist with the preparation for MDS Management Review.
Provide guidance and training to the Device sites in various quality system areas such as CAPA, Internal audits, Supplier Management, Analysis of Quality Data, Complaint Management, etc.
Supports company initiatives aimed at improving and standardizing the Quality Systems processes. Represents Businesses in Quality Networks (such as CAPA, Supplier Management, Training, Quality Notification, Customer Complaints etc.). Collaborates with the Unit/Site Quality Directors to seek their input and support in implementing the Network objectives at the BD Device sites.
Establishes and Implements worldwide policies and procedures aimed at harmonizing the Quality Systems at MDS Sites worldwide.
Manages and coordinates the Quality Systems staff. Carries out Human Resource management responsibilities such as hires, job assignments, coaching, termination recommendations, promotions, salary actions, and processes performance reviews on time.
BS in a related scientific or engineering discipline.
At least 8 years of experience in Quality, Regulatory, or Operations of a Medical Device firm.
Knowledge of US and International regulations and standards that apply to the medical device industry including FDA Quality Systems Regulations, ISO 13485, MDD, Canadian MDR.
Excellent communication skills at all levels both written and verbal.
Ability to set and deliver to specific goals and targets.
Ability to perform multiple tasks and prioritize work load.
Ability to organize and supervise people and activities.
Effective analytical, technical, and problem solving skills.
Effective meeting and presentation skills.
Effectively manage conflict.
Ability to work in or direct teams to obtain results.
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