Quality Assurance Engineering

BD; Humacao (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

BD is a leading medical technology company seeking a Quality Assurance professional to ensure CGMP-compliant quality across manufacturing and validation activities in the Humacao facility in Puerto Rico.

The role requires a Bachelor's in Engineering and 3+ years in medical device quality control/validation, with strong statistical skills and bilingual English/Spanish communication. Travel may be required, and on-site collaboration is emphasized.

Qualifications

• Bachelor's degree in Engineering or related field.
• 3+ years in quality control/validation in medical devices.
• Knowledge of CGMPs and ISO 13485 and regulatory requirements.

Responsibilities

• Review inspection criteria and procedures to assure quality standards at the most economical level.
• Investigate product complaints and implement corrective actions.
• Support cGMP compliance in validations and transfers.
• Monitor quality trends and conduct statistical investigations on quality problems.
• Audit compliance to BD procedures, specifications, and regulatory requirements.
• Provide technical and quality support to suppliers and internal teams.
• Lead defect reduction initiatives for assigned products or programs.
• Ensure staff are trained and PPE usage follows requirements.

Skills

CGMP knowledge

ISO 13485

Statistical analysis

Data interpretation

Bilingual English/Spanish

Communication skills

Travel willingness

Teamwork

Programming knowledge

Education

Bachelor's Degree in Engineering

3+ years in quality control/validation in Medical Device manufacturing

Job description

We Are The People Who Give Possibilities Purpose

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.

Job Description

Job Functions:

• Reviews inspection criteria, inspection methods and procedures to assure acceptable quality standards at the most economic level
• Investigates product complaints and directs the activities required to assure the timely implementation and documentation of corrective action
• Provides support and assures cGMP compliance in product and process validations and product and process transfers
• Monitors quality trends and conducts technical and statistical investigations on quality problems, reporting the results and recommendation in a timely manner
• Performs and review IQ’s, OQ’s and PQ’s of manufacturing, packaging, test and inspection equipment and/or process performance validations
• Conducts audits to assure compliance to BD procedures and specifications, as well as to regulatory requirements
• Plays a key role in ensuring that the Corporation and customer's quality requirements are met on assigned products, programs, areas, and functions to ensure requirements are fulfilled. This includes review operation documents, process procedures, test procedures, inspection analysis, Vendor Quality Manuals, and customer and military specifications
• Provides technical and quality support to suppliers, the Manufacturing Engineering group and to the Customer Service department on the analysis of product returned from the field
• Reviews trends and planning of overall defect reduction programs associated with their assigned products or program. Such trend information is available from formal sources, such as the quality reports and informally through frequent interaction with Supervisors, Inspectors and Production personnel
• Interacts with representatives from different groups, including Manufacturing Engineering, Purchasing, Financial Department, and all production and inspection personnel in the facility. Also, evaluates customer complaints to identify any failure trends. This may require frequent communication with Division Field Assurance Department and suppliers on quality engineering issues
• Reviews all documentation related to product quality such as test procedures, raw material, specifications, operational procedures, etc. and approves as appropriate to ensure product quality
• Improves systems, monitors performance, and identify skills, training and capabilities needed
• Monitors inspection and test results and initiate corrective actions to maintain acceptable levels
• Assures are trained before performing any task
• Uses the required clothes, personal and security protective equipment according to the requirements of its operation
• Follows the cGMP’s, Quality Standards and established policies and/or procedures
• Performs other duties assigned by supervisor

Basic Qualifications

• Must be thoroughly knowledgeable on CGMP's, ISO 13485, OSHA and familiar with other Regulatory Requirements applicable to a medical device manufacturing operation
• Must perform statistical analysis and have the ability to analyze data and communicate effectively in order to solve problems where past experience cannot necessarily be drawn upon
• Must be able to interact with different kinds of persons in a harmonious manner, being cognizant of basic corporate, divisional and departmental goals
• Must have computer programming and software applications knowledge.
• Willing to travel
• Must be bilingual (English/ Spanish) and must have good communication skills both oral and written
• Team work oriented

Education And/or Experience

• Bachelors Degree in Engineering
• Three (3) or more years' experience in the quality control and/or validation field, in a Medical Device manufacturing facility

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?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

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.

Primary Work Location

USA PR - Humacao