Senior Quality Engineer

Integra LifeSciences Corporation; Mansfield (MA); On-site; USD 81,650 - 112,700; Full time

Job summary

Integra LifeSciences Corp. is hiring a Senior Quality Engineer in Mansfield, MA to lead quality initiatives across the product lifecycle. You will analyze processes, manage non-conformances, and support audits to ensure ISO-13485 and CFR 820 compliance.

Ideal candidates have 5+ years in quality engineering, strong regulatory knowledge, and experience with IQ/OQ/PQ and TrackWise in a regulated medical device setting.

Qualifications

• Engineering or technical degree with 5+ years of experience, or advanced degree with related experience.
• Excellent organizational and English communication skills (oral & written).
• Familiarity with ERP systems (Oracle ideal).
• Experience in regulated environments; medical device or pharma preferred.
• Experience writing IQ/OQ/PQ documents and using QMS tools.

Responsibilities

• Support quality improvement initiatives and process characterizations.
• Work on non-conforming reports and root-cause investigations.
• Conduct internal and supplier audits per ISO-13485/21 CFR 820.
• Develop monitoring/control methods and perform data analysis.
• Own material identification, defect classification, and CAPA reviews.
• Plan and review validation activities; mentor engineers and technicians.

Skills

Quality Engineering

Problem solving

Communication

Regulatory knowledge

Team collaboration

Education

Bachelor’s or Master’s in Engineering

Tools

IQ/OQ/PQ

TrackWise

MS Office

ERP (Oracle)

Job description

## Senior Quality EngineerApplylocations: US-MA-Mansfield-190-Facilitytime type: Full timeposted on: Posted Todayjob requisition id: JR-6161Changing 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.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, including FMEA activities.* 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.Aid in planning, conducting and reviewing validation activities.**SKILLS & COMPETENCIES*** Engineering or Technical degree with 5+ years of experience, or equivalent education and years of management experience OR Master degree with 3+ years of experience or equivalent education and years of experience* Demonstrate excellent organizational and English communication skills (oral & written)* Financial acumen relating to operations profit & loss (P&L) items,. Including ERP systems (Oracle ideal)* Proficiency in MS Office Suite and statistical analysis software.* Experience with writing and executing IQ/OQ/PQ documents* Experience in working in an electronic QMS system (Trackwise preferred).* Experience in regulated environment; medical device or pharma preferred* Familiarity with health, safety, and environmental regulations related to manufacturing.* Experience in regulated environment; medical device or pharma preferred* Self-motivated team player with ability to work independently and collaboratively across all levels of the organization.Salary Pay Range:$81,650.00 - $112,700.00 USD SalaryOur 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**.** Your recruiter can share more about the specific salary range for your preferred location during the hiring process.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 LifeSciencesIntegra 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 | EOE including Disability/Protected Veterans 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. If you have difficulty using our online system due to a disability and need an accommodation, please email us at [e-mail].