BD Nogales Norte
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The Sr. Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality Engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance, and play an active role in the process to ensure products meet quality standards consistent with both Corporate and Unit policies, while meeting all design control and other regulatory requirements.
Job Responsibilities
Consistent application of technical principles, theories, concepts, techniques, and quality sciences/tools. Proven problem-solving skills. Makes measurable improvements to BD processes and procedures. Ensures that all design control and production/process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements. Acts as a team member representing Quality on new product development and sustaining engineering projects. Reviews and has Quality Engineering approval authority for new and modified design/process specifications including product performance specification, test methods, etc. Assists with supplier and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and good manufacturing practices (Auditor-in-training). May perform other duties as required. Education And Experience
Typically requires a minimum of a bachelor’s degree in science, engineering, or other relevant discipline and a minimum of 5 years relevant experience or a combination of equivalent education and relevant experience. Knowledge And Skills
Applied knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. - 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR) as it relates to the design and continued support of BD products. Applied knowledge of Corporate and/or Unit requirement. Able to contribute to the completion of specific programs and projects. Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers. Able to revise policies and procedures. Able to make presentations. Can independently determine and develop approach to solutions. Able to provide guidance and work direction to lower level project developers. Can design and perform development working independently within defined parameters with minimal supervision required. Experience with BD software systems utilized in the Quality Systems is desirable. Must have knowledge/specialization in one or more of the following areas: Acceptance sampling theory and application Statistical process control methods and application Measurement system/test method knowledge and analysis Quality planning Failure analysis investigation Design of Experiments Process mapping and value stream analysis Hypothesis testing Descriptive statistics Process capability analysis Basic quality tools: Pareto, box plots, histograms, scatter diagrams, etc. Risk Management Supplier quality management Auditing Design/development tools Process validation Software validation Benefits
Annual Bonus Annual Bonus 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 Salary Range Information
106 600,00 $ - 175 900,00 $ USD Annual
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Consistent application of technical principles, theories, concepts, techniques, and quality sciences/tools. Proven problem-solving skills. Makes measurable improvements to BD processes and procedures. Ensures that all design control and production/process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements. Acts as a team member representing Quality on new product development and sustaining engineering projects. Reviews and has Quality Engineering approval authority for new and modified design/process specifications including product performance specification, test methods, etc. Assists with supplier and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and good manufacturing practices (Auditor-in-training). May perform other duties as required. Education And Experience
Typically requires a minimum of a bachelor’s degree in science, engineering, or other relevant discipline and a minimum of 5 years relevant experience or a combination of equivalent education and relevant experience. Knowledge And Skills
Applied knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. - 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR) as it relates to the design and continued support of BD products. Applied knowledge of Corporate and/or Unit requirement. Able to contribute to the completion of specific programs and projects. Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers. Able to revise policies and procedures. Able to make presentations. Can independently determine and develop approach to solutions. Able to provide guidance and work direction to lower level project developers. Can design and perform development working independently within defined parameters with minimal supervision required. Experience with BD software systems utilized in the Quality Systems is desirable. Must have knowledge/specialization in one or more of the following areas: Acceptance sampling theory and application Statistical process control methods and application Measurement system/test method knowledge and analysis Quality planning Failure analysis investigation Design of Experiments Process mapping and value stream analysis Hypothesis testing Descriptive statistics Process capability analysis Basic quality tools: Pareto, box plots, histograms, scatter diagrams, etc. Risk Management Supplier quality management Auditing Design/development tools Process validation Software validation Benefits
Annual Bonus Annual Bonus 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 Salary Range Information
106 600,00 $ - 175 900,00 $ USD Annual
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