Integra LifeSciences

Integra LifeSciences

Sr. CAPA Engineer

US-NJ-Princeton-100-Headquarters · Senior

Sponsorship not specified$82k-$113kDetected 6 days ago
ComplianceBrand StrategyRecruitingFDA RegulatoryMedical DevicesCommunicationProblem SolvingMicrosoft OfficeSharePoint

About the role

  • Thinking differently is what we do best.
  • 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.
  • This individual will also work with the Sr.

Responsibilities

  • Facilitates and works with CAPA owners to support the identification of issues, investigations, root cause analysis, action plan development and completion, and verification of the effectiveness
  • Primarily hands-on worker, with instruction or supervision of others secondary to own technical work
  • Manages and/or coordinates programs within the function contributing to the achieve of department goals and operating plans.
  • Facilitate quality metrics gathering, analyzing and reporting on a regular and ad hoc basis.Support the development and rollout of standardized QMS data sources and metrics across all levels of the organization (site, division and corporate) for input into NC / CAPA or for assessment of key quality system processes
  • Building Careers.
  • The Sr CAPA Quality Engineer is responsible for coordinating CAPAs, NCs and metrics gathering in support of Integra's corporate CAPA program.
  • This Quality Engineer will work with CAPA owners to conduct root cause investigations and develop action plans and effectiveness checks.
  • The individual must possess the ability to establish and maintain effective working relationships with Integra QA, RA and Operations Team members worldwide.

Requirements

  • Bachelor degree or equivalent with 8+ years of experience, Master degree with 5+ years of experience, Doctoral degree with 3+ years of experience.
  • Experience with root cause analysis and problem-solving methodologies.
  • Ability to review and analyze documentation required critically and logically.
  • A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition.

Nice to have

  • Computer skills to include knowledge and experience using Microsoft Office (or equivalent), Teams, Sharepoint and proficient use of contact sources for regulations and compliance on the worldwide web network.
  • TrackWise use a plus.

Compensation

  • $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.

Benefits

  • Joining us is a chance to do important work that creates change and shapes the future of healthcare.
  • Manager of CAPA, NC and Metrics to ensure that performance metrics assessing the health of the corporate quality system are collected and analyzed per schedules.
  • Maintain current knowledge of FDA and any other applicable international Quality System regulations for medical devices and human tissue products.

Company info

  • 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
  • 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.
  • 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.
  • 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.
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This listing is sourced directly from Integra LifeSciences's careers page and normalized into a canonical job model.