Quality Test Engineer
BD
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Benefits offered by this job
Job summary
BD is seeking a Quality Test Engineer to plan, perform and lead lab validation activities that support the feasibility of new lab concepts and technologies for medical devices. You will manage product release activities, identify defects and trends, and ensure compliance with ISO, cGMP and regulatory standards.
You will work cross-functionally with Design Quality, Complaints and Release teams, maintain GLP/GDP practices, calibrate equipment, manage supplier qualifications, and uphold rigorous
Qualifications
- BS degree in Engineering, Science, or related discipline.
- Minimum 5 years of experience in a related field.
- Medical device, pharmaceutical, or diagnostic industry experience preferred.
Responsibilities
- Plans and performs equipment qualifications, test method validations, fixture development, and software validations as needed.
- Performs experimentation and develops methodologies for product testing and validation.
- Leads or contributes to nonconformance investigations, root cause analysis, and CAPA actions.
- Performs release testing or product testing, maintains documentation, and reviews inspection results.
- Supports supplier qualification activities and cross-functional collaboration with Design Quality, Complaints, and Release teams.
Skills
Education
Tools
Job description
We Are The People Who Give Possibilities Purpose
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.
- 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.
- 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.
- 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
- 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
- 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
- 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
- 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
- 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
- Bereavement leaves
- Military leave
- Personal leave
- Family and Medical Leave (FML)
- Jury and Witness Duty Leave
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.
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.
USA NJ - Franklin Lakes
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.
$87,200.00 - $139,500.00 USD Annual
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