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SUMMARY
The Senior Quality Engineer I will provide support for QC Laboratories and material controls at the Braintree site. This individual will provide ongoing Environmental Monitoring Performance Qualification (EMPQ) execution, laboratory readiness activities, and material control oversight supporting the Boston-to-Braintree facility transfer. The Senior Quality Engineer I 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. This position operates with the independence, technical depth, and leadership responsibility commensurate with that expected of a senior engineer. This position will report directly to the QC Manager and is primarily geared towards supporting Quality Control Operations, encompassing Inspection, Microbiology, and Analytical laboratories along with the QA Record Review and Product Release function.
RESPONSIBILITIES
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.
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.
DESIRED MINIMUM QUALIFICATIONS
A minimum of a bachelor's degree in engineering, science or a related discipline is required
A bachelor's degree with a minimum of 5+ years of Quality experience or equivalent education and years of experience OR a master's degree with 3+ years of Quality experience or equivalent education and years of experience
Previous Quality experience in a GMP medical device or pharmaceutical manufacturing environment is required.
Strong understanding of FDA QSR, ISO 13485, ISO 9001, MDR, CMDR
Previous experience supporting Environmental Monitoring Performance Qualification (EMPQ) is strongly preferred
Demonstrates excellent organizational, communication, and project management skills
Proficient with the MS Office Suite, and statistical software.
Must be able to work independently with minimal supervision.
Able to prioritize projects to meet organizational goals and objectives
ASQ CQE and Lean Six Sigma certifications are a plus
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 . 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 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.
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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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