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SUMMARY
The Senior Quality Manager, CAPA and Nonconformances (NC) has responsibilities to develop and lead the implementation plan of Integra’s Global Quality Management System Compliance Processes (CAPA and Nonconformances). Work with process and Quality Operations leadership to drive consistent best practices for CAPA and NC, Management Review and Metrics and establish global oversight. Deploy CAPA and NC processes and digital systems that improve compliance, efficiencies, and overall effectiveness. Responsible for partnering with global quality leaders to develop processes and metrics that result in attaining the company’s improvement objectives and growth strategies.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Establish and maintain the Corporate CAPA board to address company-wide Corrective and Preventive actions. Includes the identification of issues, their investigation, and implementation of actions to address nonconformances and verification of the effectiveness of the actions.
Maintain the Global Nonconformance (NC) process to ensure compliance in areas of investigation, effectiveness, timeliness, quality and thoroughness of content. Collaborate with process owners and stakeholders in Corporate, division and site to ensure the program is compliant, executable, and continuously improves.
Lead the reporting of quality system performance metrics to be used at all levels of the organization (site, division and corporate), collaborating with process owners and key stakeholders in corporate, division and site. Ensure NC and CAPA metrics are appropriately cascaded through Management Reviews.
Work closely with NC and CAPA owners to ensure timelines are met with high quality documentation.
Standardize alert and action limits for escalations to senior leaders and other stakeholders
Ensure key process indicators of NCs and CAPAs are integrated into Quality Management Reviews.
Evaluate new regulations, guidelines and industry standards and their impact on CAPA and NC activities; plan and effectively implement plans across the business to maintain compliance.
All other duties and responsibilities as assigned
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill and/or ability required for his position.
Education:
Bachelor’s degree is required, preferably in a scientific or engineering discipline.
10+ years of demonstrated quality experience in the medical product and device industry with strong concentration in US FDA QMSR and ISO 13485 compliance and quality assurance.
Proficient understanding and demonstrated practical application of medical device regulations which include CAPA, NC and Metrics.
Skills/Knowledge:
Experience with communicating with domestic and international regulatory bodies.
Strong analytical, strategic, decision making, and risk assessment abilities.
Ability to effectively collaborate with process owners and stakeholders in corporate, division and site
Highly developed technical writing and editing skills.
Excellent organizational, leadership, and interpersonal skills.
Proficient in the following computer software applications: Microsoft Office, Copilot
Exceptional interpersonal skills.
Strong organizational and communication skills (written and verbal).
Ability to travel domestically and internationally as business required.
Experience in FDA regulated environment.
Ability to interface with technical and non-technical personnel.
Ability to utilize a computer, telephone, smart phone as well as other general office equipment. Strong computer skills are required.
Salary Pay Range:
$125,350.00 - $172,500.00 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 https://jobs.integralife.com/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.
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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