Quality Test Engineer

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

Benefits

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.

• 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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