Quality Test Engineer

Regulatory Jobs; Franklin Lakes (NJ); On-site; USD 87,000 - 140,000; Full time

Benefits offered by this job

Annual bonus

Health and well-being benefits

401(k) plan

Job summary

BD is seeking a Quality Test Engineer to lead lab validation activities supporting new and improved lab concepts and technologies. Responsibilities include equipment qualifications, test method validations, and data analysis to ensure product robustness and regulatory compliance.

The role involves cross-functional collaboration, investigation of root causes, and ensuring documentation and release testing meet ISO, cGMP, and related standards.

Qualifications

• BS degree in Engineering, Science, or related discipline.
• Minimum 5 years experience or equivalent education.
• Experience in medical device, pharmaceutical, or diagnostic industries preferred.

Responsibilities

• Plan and perform equipment qualifications, test method validations, and software validations.
• Lead or contribute to nonconformance investigations and CAPAs.
• Perform release and product testing with proper documentation and trend analysis.
• Assist with supplier qualification and maintain GLP/GDP documentation.
• Support audits and ensure ISO, FDA, OSHA, ASTM compliance.

Skills

Lab instrumentation

Software validation

Root cause analysis

Document control

Cross-functional teamwork

Education

BS in Engineering/Science

Tools

Instron

Validation software

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

The Quality Test Engineer plans, performs and leads lab validation activities that support the feasibility of new/improved lab concepts or technologies (equipment, software, test methods, etc.) required to support the development of new products and/or the robustness of commercial products. Other responsibilities may include, but are not limited to, supporting product release activities, including identification of product defects and potential issues, and the management of complaints for commercially released product from investigations through data analysis and trending. This position is also responsible for proactively managing complex issues with a high level of autonomy and is accountable for the success of all activities and deliverables while ensuring related operations comply with BD policies and procedures, as well as applicable regulations and standards.

Responsibilities:

• Serves as a technical expert on laboratory instrumentation, equipment and processes.
  • Plans and performs equipment qualifications, test method validations, fixture development, and computerized software validations, as needed.
  • Performs remediation activities and implements improvements, as needed.
• Independently plans and performs experiments that support new or commercial products or technology testing. Develops new methodologies or conducts routine procedures, as needed.
• Leads or contributes to nonconformance investigations, root cause analysis, corrective / preventive actions, etc.
• Performs applicable release testing or product testing, maintains documentation, and reviews inspection results.
• Leads or facilitates applicable complaint management process of commercial product, as needed, including sample management, activities performed by support team(s) or supplier(s), reporting and trending
• Supports equipment calibration / preventive maintenance / repair activities and investigations, as needed

• Independently identifies and creates/improves procedures to address gaps in laboratory processes.
• Identifies and supports qualifications of new lab suppliers, when needed. Supports Supplier Quality team with maintenance activities for existing suppliers.
• Maintains laboratory safety and organization as well as operational and functional conditions.
• Maintains inventory of laboratory supplies, test samples, and drug/placebo.
• Ability to work effectively in cross-functional project teams, when needed. Assists Design Quality Engineers, Complaints team, and/or release teams.

• Supports audits, as needed

• Maintains good laboratory practices (GLP) consistent with BD and regulatory guidelines.

• Maintains good documentation practices (GDP) when generating test data and records in accordance to ISO, cGMP and other applicable regulations and standards.

Education and Experience

• BS degree in in Engineering, Science, or other related discipline
• Minimum 5 years experience is required or equivalent education.
• Medical device, pharmaceutical, or diagnostic industry experience preferred.

Knowledge and Skills

• Experience with software validation highly desirable
• Working knowledge of the operation of mechanical measurement equipment (e.g. Instron) desirable
• Proficient communication (written and oral), organizational and interpersonal skills.
• Ability to perform multiple tasks simultaneously and prioritize workload with minimum supervision
• Effective analytical, technical, and problem-solving skills
• Collaborative ability to work with diverse cross-functional teams
• Understanding of industry standards and regulations such as ISO, FDA, OSHA, ASTM desirable

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.

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 NJ - Franklin Lakes

Additional Locations

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You".

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

$87,200.00 - $139,500.00 USD Annual