Job Description Summary

TCI-JD168:

The Sr. Manager, Quality Systems is directly responsible for managing the development, implementation, and improvement of the BD Technology Campus India (BD TCI) Quality Management System. This position ensures that various Quality processes such as Management review, Internal Audits, Corrective &
Preventive Actions, Training, Analysis of Data, Calibration, Equipment Qualification, Design and Development and Risk Management are effectively implemented and comply with applicable standards and regulations. This role also manages external regulatory/ISO/NB inspections at the BD TCI location and supports the inspections at the various BD manufacturing sites/Design Centers/Legal Manufacturers.
The Sr. Manager, Quality Systems also supports the establishment and implementation of policies and procedures aimed at harmonizing the Quality Systems at BD sites worldwide and provides guidance and training. This position also provides the oversight and leadership to ensure the laboratory environments at BD TCI are appropriately set up and maintained along with the environmental chambers. The position provides the quality engineering oversight, and direction in problem-solving and team-building capabilities.

Job Description

The Sr. Manager, Quality Systems is directly responsible for managing the development, implementation, and improvement of the BD Technology Campus India (BD TCI) Quality Management System. This position ensures that various Quality processes such as Management review, Internal Audits, Corrective & Preventive Actions, Training, Analysis of Data, Calibration, Equipment Qualification, Design and Development and Risk Management are effectively implemented and comply with applicable standards and regulations. This role also manages external regulatory/ISO/NB inspections at the BD TCI location and supports the inspections at the various BD manufacturing sites/Design Centers/Legal Manufacturers.

The Sr. Manager, Quality Systems also supports the establishment and implementation of policies and procedures aimed at harmonizing the Quality Systems at BD sites worldwide and provides guidance and training. This position also provides the oversight and leadership to ensure the laboratory environments at BD TCI are appropriately set up and maintained along with the environmental chambers. The position provides the quality engineering oversight, and direction in problem-solving and team-building capabilities.

Primary Responsibilities are:

• Develop and implement the Quality Management strategy in collaboration with BDX quality leadership.
• Lead the development, sustenance and continual improvement of quality systems complying with 21 CFR 820 and ISO 13485 quality system requirements with a specific focus on design control.
• Execute, measure and report on the progress of the Quality Management strategic initiatives.
• Assure that the policies, procedures, and systems are designed and implemented to produce products which conform to established quality standards and comply with Industry and Government Standards.
• Provide the required Quality Engineering support and promote use of statistical tools in product design and development activities.
• Lead the Management Review process as the Quality Management Representative.
• Assume a leadership role in collaborating with Quality leaders of various Business Units and work towards continuous improvement of current Quality System practices.
• 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 to maintain appropriate levels of Quality assurance.
• Develop and apply innovative approaches within the Quality Assurance function.
• Continuously apprise Senior Management of the level of quality throughout the center.
• Prepare, maintain, and adhere to approved departmental budget.
• Contributes and collaborates as required, on various initiatives at the Site in alignment with Site Leader.

Education:

• Master’s or bachelor’s degree in a related scientific or engineering discipline.

Experience:

• Minimum 15 years of progressive experience in Quality Assurance within an FDA regulated industry.

Knowledge:

• Knowledge of standards and regulations that apply to the medical device industry (ISO 13485, 21CFR 820, ISO 14971, EU MDR, etc.).
• In-depth understanding of the application of quality systems to the medical device industry. Prior experience managing external regulatory audits preferred. Industry recognized certification in a Quality System element specialty (e.g. ASQ Certified Quality Auditor, Quality Manager) preferred.

Skills:

• Excellent oral and written communication and technical writing skills, and proven supervisory/leadership capability and working with multi-disciplinary teams.
• Entrepreneurial drive and demonstrated ability to achieve stretch goals in an innovative and fast paced design center environment.
• Ability to set and deliver to specific goals and targets.
• Ability to perform multiple tasks and prioritize workload.
• 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.
• Self-motivated /directed.
• Experience using Trackwise and SAP.
• Experience in management of QE professional and technical staff.

Required Skills

Optional Skills

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Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift