Job Description Summary

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 develops 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. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. bd.com

Job Description

The QA Specialist I is reporting to the Quality System Specialist II for detailed quality planning, both short term and long range, diagnosis of chronic quality problems (both internal and external), development of corrective action programs and maintenance of Quality System, including but not limited to support on Quality Notifications, Change Controls, and validation activities.  The position also is responsible for identifying and supporting Quality Assurance and Regulatory Compliance issues related to assigned product lines to assure compliance with FDA regulations, ISO standards, corporate directives and Company strategies.  

This position is responsible for Quality Assurance and Regulatory Compliance activities in support of new product introduction and transfers projects for the plant product lines.  In addition, is responsible to provide Quality Assurance support to capital investment, cost reduction and/or process improvements projects by establishing and adhering to the best practices standards. Supervision of personnel maybe required as part of special project and/ or regular operations.

1. Develops, administers and maintains the BDC Ltd. Quality Systems for conformance to Regulatory requirements and Company policies and documents these systems in the Quality Procedures Manual.

2. Participates with Manufacturing, Marketing and Research & Development in defining cost effective quality standards and requirements based upon product function reliability and customer’s needs.

3. In conjunction with Manufacturing, determines that existing and proposed manufacturing processes and equipment have sufficient capability to meet quality requirements by developing and analyzing capability studies, control charts and other statistical studies. Provides recommendations for the selection of or improvements to machines or process.

4. Works on moderate to complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

5. Participates in the development and review of Standard Manufacturing Procedures, Standard Operating Procedures and Standard Test Methodologies.

6. Appraises the continuing effectiveness of the quality plan in terms of quality levels, nature of manufacturing quality problems, customer complaints and economical operation. Initiates, implements and/or recommends changes to procedures, policies and specifications, when appropriate.

7. Investigates nonconforming materials, components and products for causes. Works closely with R&D, Marketing and Technical Support.

8. Maintains systems, which differentiate between regular, hazardous, USP, MDR and International complaints and provides the appropriate priorities for testing.

9. Determine the validity of all tested complaints based on product literature, standard test methods, and general field usage and test results. Recommends revisions of STM’s or product literature based on the result of complaint analysis. Develops situation analysis and internal corrective action in response to valid customer complaints.

10. Develops quality certification/qualification plans for new vendors, and “improved” finished products or processes.

11. Support on the evaluation of new vendor facilities and systems for controlling quality.

12. Bring support during in-process and finished product quality systems audits, in accordance to QSR and ISO standard.

13. Assures the development of corrective action programs.

14. Maintains an awareness of FDA and other agency regulations and industry practices.

15. Assures that all new product requirements have been met prior to market introduction. Participates in the development and review of the Product Release Document.

16. Coordinate and/or execute compliance and quality activities needed as part of new product introduction, transfers, capital investment, cost reduction and/or process improvements projects.

17. Interface with internal/external partners to understand and meet customer expectations and assure smooth cooperation in order to obtain best results in projects assigned.

18. May schedule, plan and manage validation projects and computer-based systems control and validation activities. Organizes and performs the logging and archiving of validation documents. Interpretation and application of regulatory requirements concerning validation activities.

19. Acts independently with minimal supervision to conduct approved projects/validations.

20. Adheres to all quality, environmental, health and safety policies and procedures, including any department specific requirements.

POSITION REQUIREMENTS

Education:

B.S. in Engineering, Microbiology, Biology or Medical Technology with courses in Microbiology and in Chemistry, or experience commensurate with required knowledge.

B.         Experience:

Minimum of five (5) years of general laboratory experience or equivalent.  

Must have knowledge of government regulations for Medical Devices (General IVDD and specific for the various product lines, e.g. CDC, CLSI, etc.).

Ability to manage multiple activities and constantly change priorities.

Knowledge in the creation of validation protocols and re qualification programs, including all reviewing process following GMP’s.

Must possess the ability to communicate clearly and effectively with all levels of management in all departments.

Good experience with statistical analysis using Minitab or similar statistical software. In addition, must possess knowledge of Microsoft Office software (Word, Power Point, Excel, Outlook, etc.).

Must have practical knowledge of current QSR’s, GLP’s, ISO 9002, Quality Systems procedures and manufacturing operations relating to all BDC Ltd. products.

Good communication skills (written and oral) in English and Spanish.

Supervision:

Position does not directly supervise nor have a direct report.

Mental or Visual Demand:

Needs to apply principals of logical thinking and common sense to collect data, establish facts and draw valid conclusions.  Interprets instructions furnished in written or oral form.  Prepares business letters, summaries and reports, using standard formats and conforming to rules of punctuation and grammar.  Conducts training sessions.  Requires good communication skills to transmit information to personnel at all levels, including Business Unit personnel.

Physical Demand:

Office work.  Some standing and walking.

Working Conditions:

Good working conditions.  No exposure to adverse conditions.

Primary Work Location

USA PR Cayey - Vicks Drive

Additional Locations

Work Shift

US BD 1st Shift 830am-5pm (United States of America)