Quality Technician - Combination Products

Position Summary:

Primary focus of this position is to assist Quality Engineering activities for medical device process development, design controls, performing testing, and collecting and analyzing data.

Essential / Key Job Responsibilities (including supervisory and/or fiscal):

1. Product Builds: Assist and coordinate with manufacturing sites for the build of product part or prototypes for engineering evaluation, validation, pre-clinical and clinical studies, marketing and commercial sales.

2. Product: Assist in execution of product rework and/or inspection activities.

3. Process: Assist in device master record (DMR) documentation changes/updates

4. Design: Assist in device design history file (DHF) changes/updates

5. Documentation: Assist, prepare, develop, and implement documentation including work instructions, standard operating procedures, technical reports, change requests and test protocols which align with GMP and Quality requirements.

6. Test Method Development: Review test methods during test method development and assists with test method validations.

7. Testing: Conduct tests as per mentorship from development engineers; collect and document test results; verify data; analyze and format test data for reporting.

8. Training: Provides process/test method training to manufacturing and operations personnel.

9. Assists in quality data compilation for tracking and trending quality metrics including device post-market analysis

10. Provide summary reports to quality engineering on status of deliverables.

11. Other responsibilities may include, however are not limited to:

o Help support Manufacturing, Quality, Regulatory & R&D to make sure systems are aligned with all internal and external guidelines.

Required Qualifications:

• Minimum of a Highschool Diploma/GED.
• Experience: 0-3 years of industrial experience in Quality or process development
• Proficiency in carrying out tasks, gathering data, and detailing outcomes.
• Experience working in a laboratory and a controlled environment (cleanroom) is a plus.
• Ability to assist in completing validations
• Ability to operate lab equipment
• Basic computer skills (MS Windows, MS Outlook, Word, Excel and PowerPoint)
• Basic math/statistics skills.

Preferred Qualifications:

• Associates of Science degree in a technical field
• Medical device or other regulated FDA/QSR and ISO environment.

Education and/or Experience:

• Minimum of a Highschool Diploma/GED. Associates of Science degree in a technical field preferred.
• Experience: 0-3 years of industrial experience or process development preferably in medical device or other regulated FDA/QSR and ISO environment.

Physical Demands:

While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

Work Environment:

While performing the duties of this job, the employee may be in an open cubicle environment, lab, or cleanroom. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

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/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.

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Required Skills

Optional Skills

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Primary Work Location

USA AZ - Tempe Headquarters

Additional Locations

Work Shift

NA (United States of America)