Quality Assurance Engineering

Becton Dickinson; Humacao (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

Becton, Dickinson and Company is seeking a Quality Assurance professional for on-site operations in Humacao, PR. The role focuses on ensuring CGMP compliance, reviewing inspection criteria, and leading corrective actions for product quality and process effectiveness.

You will perform audits, support validations, and collaborate with Manufacturing Engineering, Purchasing and Customer Service to maintain our high standards.

Qualifications

• Must be thoroughly knowledgeable on CGMPs, ISO 13485, OSHA and familiar with other regulatory requirements.
• Must perform statistical analysis and communicate effectively to solve problems.
• Ability to interact with diverse personnel while aligning with goals.
• Must have computer programming and software applications knowledge.
• Willing to travel and bilingual English/Spanish.
• Teamwork oriented.

Responsibilities

• Review inspection criteria, methods and procedures to assure quality at the most economical level.
• Investigate product complaints and implement corrective actions with documentation.
• Support cGMP compliance in validations, processes and transfers.
• Monitor quality trends and conduct technical investigations with timely reporting.
• Review IQs, OQs and PQs of equipment and process validations.
• Conduct audits to ensure compliance with BD procedures, specifications, and regulatory requirements.
• Provide technical and quality support to suppliers, Manufacturing Engineering and Customer Service.
• Review trends and plan defect reduction programs for assigned products or programs.
• Communicate with cross-functional groups to address quality issues and customer complaints.
• Review all documentation related to product quality and approve as appropriate.

Skills

CGMP knowledge

Statistical analysis

Data interpretation

Quality investigations

Bilingual (English/Spanish)

Education

Bachelor's Degree in Engineering

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

• 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

Workplace Arrangements

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. 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

Required Skills Optional Skills . Primary Work Location USA PR - Humacao Additional Locations Work Shift We are the #MakersofPossible Working together, we make products that patients, families and their healthcare professionals rely on. We do this because we are committed to advancing the world of health. But it takes the imagination and passion of all of us at BD, from manufacturing to marketing, to look at the impossible and find solutions that turn dreams into possibilities with real-life health benefits for people today, tomorrow and beyond. We make this happen, together. We are the makers of possible.

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.