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.

The Senior Quality Engineer is responsible for ensuring the manufacture of safe, compliant, and high-quality medical devices by maintaining effective quality systems, supporting manufacturing and engineering operations, and driving continuous quality improvement. They plan and execute of their duties in compliance with site and enterprise procedures, corporate policies, U.S. Food and Drug Administration regulations, Good Manufacturing Practices (GMP), ISO 9001, ISO 13485, EU MDR, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies. These positions operate with increasing independence, technical depth, and leadership responsibility commensurate with level assignment.

CORE RESPONSIBILITIES (ALL LEVELS)

• Ensure compliance with FDA QSR, ISO 13485, ISO 9001, MDR, CMDR, and internal quality system procedures.

• Review, approve, and support quality records including nonconformances, investigations, CAPAs, change controls, validations, and risk documentation.

• Provide quality engineering support to manufacturing operations, including inspections and data analysis.

• Participate in internal and external audits including FDA inspections and ISO surveillance audits.

• Apply statistical and risk-based tools such as SPC, FMEA, and sampling plans. • Support complaint investigations, KPI monitoring, and SPC trending to drive product and process improvements.

• Collaborate cross-functionally with Manufacturing, Engineering, Regulatory, and Supply Chain.

• Support Quality Management Reviews and performance metrics.

SENIOR QUALITY ENGINEER I

• Lead complex investigations, CAPAs, and cross-functional quality initiatives.

• Serve as subject matter expert for assigned products, processes, or quality systems.

• Approve high-impact validations, change controls, and risk documentation.

• Drive continuous improvement initiatives using Lean, Six Sigma, and advanced statistical methods.

• Provide guidance and mentoring to junior Quality Engineers.

Education/Experience:

• Bachelor’s degree in engineering or science; 5–8+ years Quality Engineering experience; ASQ CQE or Lean Six Sigma preferred.

TOOLS & SYSTEMS: QMS platforms (e.g., TrackWise), ERP systems, statistical analysis tools (Minitab/SPC), CRM platforms, project management software (e.g., MS Project, Jira), Microsoft Office Suite.

PHYSICAL REQUIREMENTS: The physical requirements listed below represent the motor and physical abilities necessary to successfully perform the essential duties of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to enable individuals with disabilities to perform these duties.

While performing the responsibilities of this role, the employee is expected to:

• Work in manufacturing, cleanrooms, laboratory, and office environments.

• Sit, listen, speak, and move throughout various areas of the building.

• Travel across all company locations as needed.

• Periodically lift and/or move items up to twenty-five pounds.

• Travel domestically and internationally via car, train, or airplane, as required by the role.

ADVERSE WORKING CONDITIONS: The conditions listed below represent environmental factors which the employee may be exposed to while performing the essential duties of this position. These reflect a general plant or service environment. Adverse exposure may include handling hazardous and biohazardous materials such as:

• Flammable and corrosive liquids

• Compressed gases

• Sharps

• Medical waste Appropriate safety protocols and personal protective equipment (PPE) are required and provided.

In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role.

DISCLAIMER The responsibilities and duties outlined above are intended to illustrate the general nature and level of work performed by individuals assigned to this position. They do not represent an exhaustive list of all tasks that may be required. Additional duties may be assigned as appropriate to meet business needs. This job description does not constitute a contract of employment and is subject to change at the discretion of the employer, based on evolving organizational requirements and role expectations.

Salary Pay Range:

$51,000.00 - $71,000.00 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 trainingIn addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensationYour 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 LifeSciences

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 | 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 careers@integralife.com.

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

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