Senior Quality Compliance Specialist

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 DESCRIPTIONThe Senior Quality Compliance Specialist has responsibility for supporting overall site Quality Management System (QMS) compliance. This position will support the Quality Compliance team and supports the site CAPA program, Quality Management Review preparation, Quality metrics, and the internal audit program. This position will support external audits in the capacity of backroom leadership and audit preparation. Works closely with all functional leaders to ensure on-going compliance and improvement.ESSENTIAL DUTIES AND RESPONSIBILITIESTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily.Primary responsibilities are to:Support the QMS processes and activities at the site.Supports, and may lead, the development of new processes, standards, or plans in support of the organization’s strategies.Prioritizes the completion of activities and projects to meet business needs.Ensures ongoing site compliance to documented processes, current Good Manufacturing Practices, and applicable regulations / standards.Support or lead Internal Audit Program, including conducting Internal AuditsSupport of CAPA process, including coordination of CAPA Review Board (CRB).This role requires experience in the back room of external audits, and preferably experience with FDA inspections.Quality Management Review Coordination and preparation.Quality Plan project management to ensure timely completion.Support external audits including preparation and leadership/coordination of Backroom personnel and activities.Leads or supports quality initiatives/projects as assigned.Operates effectively with minimal supervision.Other activities as assigned.DESIRED MINIMUM QUALIFICATIONSThe requirements listed below are representative of the knowledge, skill, and/or ability required for this position.Bachelor’s degree in Engineering, Life Science, or a related field with 5+ years' experience in QA/Compliance within the medical device or similar industry or equivalent education and years of experienceOr Master’s degree with 3+ years of experience or equivalent education and years of experienceOr Doctoral degree with 0-2 years of experience or equivalent education and years of experienceWorking knowledge of 21CFR 820, 806, 803, Part 11, Part 4; ANVISA, TGA, Health Canada, EU, China & Japan regulations; ISO 13485, MDSAP, etc.Previous experience with effective root cause investigation, corrective and preventive action planning, execution and verification of effectiveness techniques. Experience with quality tools and process improvement techniques.Experience as a Back room Lead during external audits (e.g., Notified Bodies and FDA).Exceptional quality system and regulatory documentation writing and editing skills (e.g., CAPA records, audit NC responses).Knowledge and direct experience with CAPA processes and records, including investigational techniques and CAPA boards.Certified Quality Auditor is a plus.Experience reviewing technical documentation.Strong written and verbal communication skillsStrong critical thinking and analytical skillsSalary 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 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 VeteransIntegra 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 View email address on click.appcast.io Agency SubmissionIntegra 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.Integra - Employer Branding from Integra LifeSciences on Vimeo #J-18808-Ljbffr