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

POSITION SUMMARY

As directed by the Quality Manager, the Sr. Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality Engineering skills for medical devices.  This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and Unit policies, while meeting all design control and other regulatory requirements.

Duties and Responsibilities

• Works closely with other functions within the organization (Manufacturing, R&D, Quality, Engineering, Procurement, Marketing)
• Responsible for ensuring the quality of the product and process for the assigned product line(s).
• Develops, modifies, applies and maintains quality standards and protocols.
• May be responsible for developing and implementing strategic quality plans, master validation plans, validation protocols, inspection plans and quality/regulatory compliance operating procedures to meet FDA (Food and Drug Administration) and ISO (International Organization of Standardization) requirements.
• May be responsible for developing, documenting and/or maintaining design history files.
• Proven problem solving skill.
• Assist with supplier and internal quality system audit as a means of evaluating the effectiveness of the established Quality System and Goo Manufacturing Practices.
• Responsible for technical oversight that include investigation, validations and Product Assessment.
• May be expected to make presentations.
• Prepares/revises policies/procedures
• Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and lower level project developers.

Knowledge and Skills

• ​Thorough knowledge of quality system regulations/requirements (i.e. ISO-International Organization for Standardization, FDA-Food and Drug Administration, GLP / GMP-Good Lab / Manufacturing Practices, QSR-Quality System Regulation, EPA- Environmental Protection Agency).
• Effective communication skills at all levels both written and verbal ( English and Spanish)
• Effective skills in analytical thinking and problem solving.
• Ability to perform multiple tasks and ability to effectively manage conflict.
• Ability to work in teams to obtain results, self-motivated/directed, ability to organize and supervise people and activities, minimal supervision required.
• Knowledge of manufacturing processes and relevant statistical techniques (Six Sigma, Statistical Process Control (SPC).
• Basic to intermediate proficiency in Microsoft Office and statistical programs (i.e. MiniTab, SAS).
• Understanding of continuous improvement methodologies including lean, six sigma, and validation.
• Professional certification is preferred (i.e. CQA-Certified Quality Auditor, CQE-Certified Quality Engineer, SQE-Software Quality Engineer, CQM-Certified Quality Manager, etc.).
• SAP experience preferred.

Education

• BS degree in Life Sciences, Engineering (Biology, Chemistry, Microbiology, Electrical, Mechanical, Software/Computer Science).

Experience

• A minimum of 5 years relevant experience or a combination of equivalent education and relevant experience.
• Applied knowledge of applicable regulatory, Corporate and or Unit.

Primary Work Location

USA PR Juncos - Road 31

Additional Locations

Work Shift