Quality Engineer I

Changing lives. Building Careers.

Joining us is a chance for you 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, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

The main duties of the role are to support the site in maintaining strong and compliant quality processes by providing technical expertise and ensuring the proper execution of key quality activities. The role contributes to the control and improvement of product and process quality through nonconformance management, validation support, risk analysis, audits, CAPA, and GMP compliance. It also provides guidance to teams, supports investigations and documentation updates, and helps drive continuous improvement to ensure reliable and compliant operations.

RESPONSIBILITIES

• Ensure adequate application of Quality, Environmental, Health & Safety ILS policies and procedures.
• Ensures adequate Quality support is provided to production teams as well as to ongoing projects and initiatives.
• Ensure that Nonconformances are initiated, dispositioned, approved, and investigated according to plans, procedures, and regulatory requirements.
• Ensure that quality activities related to the validation of new processes and products are performed and documented according to procedures and within defined timelines.
• Write protocols and reports for validation documentation (e.g., process validation, test method validation, validation plans). 
• Ensure that risk analysis activities (PFMEA) are completed and documented in line with procedures and within the required timeframes.
• Organize meetings for risk analysis activities and prepare corresponding risk management documentation.
• Ensure that GMP rules are understood, applied, and respected onsite.
• Support teams by providing clear guidance and occasional training on quality requirements and best practices.
• Provide technical support to the QC and laboratory departments.
• Escalate quality issues and ensure that appropriate and compliant corrective actions are implemented.
• Actively participate in internal and external audits/inspections, contributes to preparation activities, and supports the timely closure of audit actions
• Lead or participate in Quality-related projects.
• Provide support for complaint investigations when required.
• Contribute to the creation, review, and revision of procedures, work instructions, and quality documentation to ensure clarity and compliance.
• Ensure CAPAs are effectively managed, monitored, and documented, including evaluation of root causes, action effectiveness, and compliance with deadlines.
• Support process improvement initiatives. 

QUALIFICATIONS

• A minimum of a Bachelor’s Degree is required, preferable in Engineering, a Life
• Science or a related technical discipline.
• Experience working in a Medical Device manufacturing environment is preferred.
• Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC, 21 CFR part 820
• Capable of both written and verbal effective communication skills in English and in French including presentations as assigned.
• Good communication, organizational, negotiation and interpersonal skills
• Good analytical problem-solving skills.
• Use of Agile, Oracle, EtQ, Trackwise, ICDH, Minitab
• Use of Microsoft office tools
• Good knowledge of statistical techniques
• Fluent in French and English.

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.