Job Description Summary

This position reports to the Sr. Quality Manager.

The Quality Systems Manager is responsible for providing Quality and technical leadership and supervision to product, systems, and direct report teams. Coordinates team activities to ensure Quality and Plant goals are accomplished and communication occurs between the function and operations team.

The Quality Systems Manager is responsible for maintaining the internal Quality Audit program in compliance with the regulatory and ISO requirements. He / She is responsible of the development and execution of the internal audit schedule performing as a Lead Auditor, organizing, and leading the internal quality audit, managing the audit team, reporting non conformances and opportunities for improvement, evaluating corrective actions, and determining its effectiveness.

The Quality Systems Manager will facilitate regulatory inspections and coordinate the efforts to correct any third-party audit deficiencies. He / She will collaborate in the quality education activities including customizing courses to meet different compliance needs. Also, the Quality Systems Manager will coordinate the activities and maintain communication with the US BDB Cell Analysis Sites for customer complaint investigations (PIR’s). Maintains track and trending on Non-Conformance investigations and performs as the CAPA Coordinator, for the evaluation of corrective actions and verification of its effectiveness. Actively participates on the Supplier Management Program.

Job Description

We are the makers of possible 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

DUTIES AND RESPONSIBILITIES

• The Quality Systems Manager, in conjunction with the Sr. Quality Manager, is responsible for ensuring Quality Systems conformance for the plant. He / She provides recommendations for modifications to operating policies, procedures and practices that can affect the site and the operating unit. Oversees and participates in the development, documentation, administration, and maintenance of Quality Systems for conformance to regulatory requirements and company policies.

• The Quality Systems Manager will perform as Lead Auditor during internal audit activities, developing and executing the internal audit schedule per company procedures and regulatory requirements reporting non-conformances and opportunities for improvement to Site Management, monitoring and reporting corrective / preventive actions progress and determine its effectiveness.

• Report Quality Audit Program results, customer complaints, Quality Notifications trending and status, CAPA metrics, Customer feedback and Customer satisfaction during Management Reviews.

• He / She will coordinate Management Review Meeting activities and presentations, taking and publishing meeting minutes, following-up action items and keeping the related records.

• Gathers information regarding Customer Satisfaction presents results during Management Reviews and follow-up action items and keeps related records.

• In conjunction with the Procurement Group, will actively participate in the Supplier Management Program performing audits as assigned, reporting results and provides support in the resolution of supplier related issues.

• Coordinates material and product disposition with the Planning Group and the Quality Assurance Associates and Technicians in order to prioritize activities per the production plan.

• Active participation facilitating outside regulatory agencies (such as FDA, ISO, OSHA, and EPA) inspection/audits.  Acts as a facilitator for the inspection of BDB.  Coordinate the necessary team/personnel to correct any audit deficiencies.

• Assures that all investigations related to materials and/or products are completed and closed in accordance to the established Standard Operating Procedures prior to grant disposition.

• Actively participates and provide status of material/product disposition activities during production planning meetings.

• Responsible for the reporting of assigned Quality Metrics.

• May act as the site Quality Manager during his/her absence as per established delegation of authority.

• Develops and maintains the Quality Education Program which includes GMP/Quality training.  Develops course materials and appropriate supporting documents for quality oriented GMP training. Customizes and/or restructures courses to focus on the different compliance needs of various functional groups.

• Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements.  Participates as required in training on regulatory issues affecting own area of work.  Brings regulatory compliance questions/issues to the attention of management.

• Promotes a safe environment. May provide recommendations on maintaining the safety of the work environment.  Participates in Environmental Health and Safety (EH&S) programs.  Address corrective actions whenever a hazard is identified.

• Provide recommendations to support systems that continuously improve product/process quality and product availability, reduce cost, and increase production capability.

• Actively support Continuous Improvement efforts by leading and/or participating in blitzes and CI projects as required.

• Assists with and monitors budget for capital expenditures and labor. Helps assure adequate resources are provided and are utilized in the most efficient and cost-effective manner.

• Responsible in hiring, training, and supervising of documentation systems personnel, validation personnel, validation contractors, and Quality Assurance personnel.

• Carries out Human Resource management responsibilities such as hires, job assignments, termination recommendations, transfers, promotions, salary actions, and processes performance reviews on time.

• Exercises responsibility for associate training and development and motivating supervised associates.

• Performs other related duties and assignments as required.

MINIMUM QUALIFICATIONS

KNOWLEDGE AND SKILLS

• Knowledgeable of current regulatory and ISO Standards requirements for pharmaceutical/medical devices industry.

• Demonstrated ability to lead, motivate and accomplish results through direct reports and peers.

• Ability to organize and prioritize assignments providing direction to assigned functional teams.

• Effective skills on analytical thinking, problem solving, non-conformance and customer complaint investigation, corrective and preventive action implementation, and effectiveness verification.

• Strong statistical knowledge.

• Training skills.

• Effective skills in interpersonal relationships, written and oral communication, planning/organization, and meeting’s development and participation.

• Computer literate (MS Office, Statistical Software)

• Project Management Skills

• Fully Bilingual (English and Spanish).

• Willing to travel to US and mainland and offshore.

EDUCATION AND EXPERIENCE

• Requires a Bachelor Degree in a related scientific discipline (such as Chemistry, Biochemistry, Microbiology Biology, and Engineering) and a minimum of five years of quality assurance/regulatory affairs experience in a pharmaceutical/medical device environment or equivalent combination of related education and experience.

• Formal training and a minimum of two years of experience in Quality Auditing.

SUPERVISION​

• Supervision of exempt and/or nonexempt associates and coordination of the project activities.

MENTAL DEMAND

• Apply principles of logical or scientific thinking to define problems, collect data, establish facts, and draw valid conclusions.

• Manage stressful situations.

PHYSICAL DEMAND

• Occasionally, the work requires standing and seeing (visual color discrimination). 

• Frequently, the job requires walking and sitting. 

• Constantly, the work requires fingering, talking, hearing, and seeing (near/far vision)

WORKING ENVIRONMENT

• The work is performed constantly inside the building. 

• The work requires exposure to extreme cold temperature changes.  

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

USA PR Cayey - Vicks Drive (BDB)

Additional Locations

Work Shift

US BD 1st Shift 8am-5pm (United States of America)