Staff Quality Systems Specialist I

BD Mexico; Franklin Lakes (NJ); On-site; USD 136,000 - 217,000; Full time

Benefits offered by this job

Annual Bonus

Potential Discretionary LTI Bonus

Phone use reimbursement

Medical coverage

Health Savings Accounts

Flexible Spending Accounts

Job summary

BD is seeking a qualified professional to oversee site CAPA processes, audits, and quality systems at the USA NJ – Franklin Lakes location. You will act as a CAPA SME, coordinate internal and external audits, and drive continuous improvement across cross-functional teams.

The role requires a BS in Engineering/Science and at least 8 years in medical device or related industries, with extensive regulatory knowledge and problem-solving abilities. A comprehensive benefits package is offered.

Qualifications

• Strong knowledge of US and international regulations (21 CFR 820, ISO 13485, MDR/MDSAP).
• Excellent communication, organizational and interpersonal skills.
• Ability to manage multiple tasks with minimal supervision.

Responsibilities

• Develops site procedures and policies; updates unit procedures.
• Leads CAPA processes and board meetings; interfaces with WW CAPA Board.
• Acts as CAPA SME for content and TrackWise usage; monitors CAPA completion.

Skills

Regulatory knowledge

Communication

Analytical skills

Problem solving

Auditing

Cross-functional collaboration

Presentation skills

Education

BS in Engineering/Science

Tools

TrackWise

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 Responsibilities

• Develops applicable Site / Unit procedures / work instructions and may make updates to Unit level procedures and policies.

• Serves as the Site CAPA Leader

• Acts as Subject Matter Expert to CAPA end users regarding CAPA content and Trackwise utilization.

• Leads site CAPA Board meetings and liaises with the WW CAPA Board to ensure timely completion of CAPA activities and identify areas of improvement/escalation

• Serves as the site Audit Manager

• Collaborates with the PS Internal Audit Program Manager to assess risks and ensure site internal audit requirements are met

• Ensures systematic execution of all required internal, external (FDA, ISO, etc.) and customer audits

• Supports pre- and post-inspection activities, which may include but are not limited to hosting and logistics, coaching subject matter experts, record review, and tracking of responses, actions and other audit closure activities.

• Acts as Subject Matter Expert regarding audit process and electronic tools utilization.

• Serves as the site coordinator for Quality Notifications (NCs and Planned Deviations)

• Acts as Subject Matter Expert regarding QN content, process, and electronic tools utilization

• Supports end users in meeting timely completion of QN related activities

• Leads or supports problem-solving and root cause analysis activities, as needed. Coaches cross-functional teams as a problem-solving subject matter expert.

• Tracks trends of various Quality Data sources (CAPA, Audits, QNs, etc.). Analyzes and reports on metrics.

• Assists with Management Review content development and related activities.

• Maintains Site and WW Quality Systems. Supports continuous improvement initiatives.

• Collaborates with cross-functional partners such as Quality Engineering, R&D, Operations, Medical, Marketing to seek their input into the development of policies and procedures, and their support in addressing Quality Issues.

Education and Experience

• BS degree in in Engineering, Science, or other related discipline

• At least 8 years of medical device, biologic, pharmaceutical, or diagnostic industry experience.

Knowledge and Skills

• Strong knowledge of US and International regulations and standards that apply to the medical device industry including 21CFR820, ISO 13485, MDD/MDR, MDSAP country requirements as well as other requirements applicable to the product.

• Proficient communication, organizational and interpersonal skills.

• Ability to perform multiple tasks and prioritize workload. Self-motivated / directed, require minimum supervision

• Effective analytical, technical, and problem-solving skills.

• Effective meeting and presentation skills.

• Ability to perform and/or host internal / external audits.

• Collaborative ability to work in teams to obtain desired results.

At BD, we are committed to supporting our associates’ well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role:

• Annual Bonus

• Potential Discretionary LTI Bonus

• Potential reimbursement of phone use

Health and Well-being Benefits

• Medical coverage

• Health Savings Accounts

• Flexible Spending Accounts

• Dental coverage

• Vision coverage

• Hospital Care Insurance

• Critical Illness Insurance

• Accidental Injury Insurance

• Life and AD&D insurance

• Short-term disability coverage

• Long-term disability insurance

• Long-term care with life insurance

Other Well-being Resources

• Anxiety management program

• Wellness incentives

• Sleep improvement program

• Diabetes management program

• Virtual physical therapy

• Emotional/mental health support programs

• Weight management programs

• Gastrointestinal health program

• Substance use management program

• Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit

Retirement and Financial Well-being

• BD 401(k) Plan

• BD Deferred Compensation and Restoration Plan

• 529 College Savings Plan

• Financial counseling

• Baxter Credit Union (BCU)

• Daily Pay

• College financial aid and application guidance

Life Balance Programs

• Paid time off (PTO), including all required State leaves

• Educational assistance/tuition reimbursement

• MetLife Legal Plan

• Group auto and home insurance

• Pet insurance

• Commuter benefits

• Discounts on products and services

• Academic Achievement Scholarship

• Service Recognition Awards

• Employer matching donation

• Workplace accommodations

Other Life Balance Programs

• Adoption assistance

• Backup day care and eldercare

• Support for neurodivergent adults, children, and caregivers

• Caregiving assistance for elderly and special needs individuals

• Employee Assistance Program (EAP)

• Paid Parental Leave

• Support for fertility, birthing, postpartum, and age-related hormonal changes

Leave Programs

• Bereavement leaves

• Military leave

• Personal leave

• Family and Medical Leave (FML)

• Jury and Witness Duty Leave

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 NJ - Franklin Lakes

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$135,500.00 - $216,800.00 USD Annual

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.