Job Description Summary

This position is responsible to lead investigations resulting from customer complaints, Quality Notifications, audit findings, and other sources as required by using structured root cause analysis and problem-solving techniques. Interact professionally with internal associates, associates from other BD manufacturing plants, suppliers, Regional Quality Units, and WW Quality Units to support resolution of customer quality issues. Use investigation results to continually assess the adequacy of process and systems, issuing corrective actions as required to maintain an effective quality system. Supports the quality of material and product by verifying standard operating procedures (SOP’s), product specifications and Good Manufacturing Practices (GMP). Ensures compliance with BD quality systems, policies, procedures, and best practices, and all local, state, federal and BD safety regulations, policies and procedures. Regular, punctual attendance is an essential job function. Ability to read and write and converse in English. Willing and able to uphold BD Values.

Job Description

We are the makers of possible 

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. 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

1st shift – Monday-Friday 8:00AM-5:00PM

JG3

PCP Level 1

Responsibilities include but are not limited to:

1. Investigation, prioritization, and timely response for customer complaints.

2. Assess the complaint vs. established quality criteria. Determine the investigation path (valid vs. information).

3. Effectively communicate findings thru technically written, data focused reports.

4. Thoroughly investigate the non-conformance, driving to a root cause and robust corrective and preventative actions.

5. Review batch records, change control, validation, Quality Notification trends, and other data sources as required as part of the investigation process.

6. Work with the other Customer Quality Specialists to ensure all complaints are being investigated and timelines for the investigation are consistently met.

7. When applicable coordinate and lead the correct “team” to investigate higher priority complaints.  

8. Prepare and communicate recommendations for improvement of both processes and systems based on investigation results.  

9. Understand and be proficient in the CAPA system.

10. Perform trend analysis of customer complaints.

11. Update procedures as necessary.

12. Track and trend Quality Notifications

13. Support the month end Quality reporting (local and WW Quality metrics).

14. Assist NS (non-sterile) batch release on an “as need” basis.

15. Assist or lead Engineering Studies / Special Test Requests.

16. Project work, coaching and leading of work related to Quality Investigations and Customer complaints.

17. Support the internal audit program.

18. Other duties as required to support the needs of the business.

• On time customer response to complaints and general inquiries

• Timely and accurate communications/updates to Quality supervision and site’s functional groups regarding any quality issues, specifically around customer complaints / Quality Notifications.

• Responsible to monitor that materials and product consistently meet Customer and Quality specifications.

• Understand the reporting of and compliance to Worldwide defined metrics

• Ability to learn and author SA’s (Situational Analysis) reports when required.

Supervision:

• This position does not supervise any associates at any level

Education and Experience

Minimum Education :

• Required :  HSD/GED

• Preferred :  BA/BS – Engineering or other relevant field

Minimum Experience :

• 1-3 years GMP experience

• Pharmaceutical/medical device experience preferred

• 1–3 years’ experience with root cause investigation tools.

• 1-3 years working with within a “team environment”

Knowledge and Skills

Basic :

• Team Building skills

• Statistical analysis skills

• Analytical skills

Proficient :

• Communication skills

• Problem solving skills

• Root cause investigation skills

• Technical writing skills

• Quality system knowledge (cGMPs and ISO)

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.

BD is committed to providing a robust set of value-based programs and resources that are best-in-class, market-competitive and affordable for all associates and their families.

• Competitive pay

  • Access a portion of your pay before pay day with DailyPay

• Healthcare coverage:No paycheck contributions for eligible associates under a certain salary threshold enrolled in the HSA Basic Medical Plan option, no matter how many dependents you cover.

  • Preventive care covered at 100%.

  • Dental and vision insurance at group rates.

• Paid parental leave up to 6 weeks

• Adoption assistance plan

• 401(k) plan with 75 cents on the dollar matched by BD up to 6% of compensation

• Company paid basic life and AD&D insurance

• Tuition reimbursement

• Discounted home, auto and pet insurance

• Paid holidays and vacation (pro-rated the first year based on actual start date)

All benefits and policies are subject to eligibility and enrollment requirements. Most coverage begins on your first day or the date you become eligible for benefits.

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 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

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Primary Work Location

USA NE - Columbus (East)

Additional Locations

Work Shift