Senior Quality Engineer I

Integra LifeSciences; Massachusetts; On-site; USD 82,000 - 113,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) savings plan

Job summary

Integra LifeSciences seeks a Sr. Quality Engineer to drive quality improvements across the product lifecycle. You will lead risk-based analysis, CAPAs and supplier audits while mentoring engineers and technicians on quality systems and processes.

In this role you will analyze data for process improvements, oversee nonconformances, and ensure regulatory alignment with ISO-13485 and FDA standards. The position emphasizes manufacturing knowledge and cross-functional collaboration to safeguard

Qualifications

• Bachelor's degree or equivalent with 8+ years of experience, Master degree with 5+ years, Doctoral degree with 3+ years.
• Manufacturing/operations experience required.
• Strong knowledge of FDA and ISO product/process risk management and risk mitigation.
• Experience with CAPAs, NCs and internal/supplier audits.

Responsibilities

• Support quality improvement initiatives and process/product characterizations for cost improvements.
• Work on non-conforming reports: initiate, analysis, investigation, review and close.
• Collaborate with third-party suppliers to resolve NC issues.
• Conduct internal/supplier audits per ISO-13485 and/or 21 CFR 820.
• Develop and implement process monitoring methods aligned with risk.
• Collect data and perform statistical analyses for process improvements.
• Investigate and document nonconformances, CAPAs and customer complaints.
• Own material identification, segregation and defect classification in manufacturing.

Skills

Risk Management

Quality Engineering

Statistical Analysis

Root Cause Analysis

Manufacturing Knowledge

Education

Bachelor's degree or equivalent

Master's degree

Doctoral degree

Tools

ISO-13485

21 CFR 820

Job description

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

SUMMARY

The Sr. Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The individual will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. The individual will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business and supervise, lead and mentor other engineers and technicians.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
• Work on non-conforming (NC) reports (Initiate, Analysis, Investigation, Review and close).
• Work with third party supplier to resolve issues with NC.
• Conduct Internal/Supplier Audits of the facility per ISO-13485 and/or 21CFR820.
• Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
• Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
• Conduct investigation, bounding, documentation, review and approval of nonconformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
• Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
• Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
• It is also understood that an associate may receive special projects outside of this list.

DESIRED MINIMUM QUALIFICATIONS

• Bachelor's degree or equivalent with 8+ years of experience, Master degree with 5+ years of experience, Doctoral degree with 3+ years of experience
• This position will require relevant experience working in manufacturing/operations.
• In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
• Experience with a proven track record of implementing appropriate risk mitigation.
• Good technical understanding of manufacturing equipment and processes is required.
• Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.

Salary Pay Range

$81,650.00 - $112,700.00 USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation.

Additional Description for Pay Transparency

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences (https://www.integralife.com/careers/total-rewards)

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:

EEO Is the Law (https://www.eeoc.gov) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs