QA - CAPA Specialist

Capa Specialist

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.

The CAPA Specialist is responsible for supporting the site Quality Management System (QMS) Corrective and Preventive Action (CAPA) program. Primary responsibilities include owning CAPA's, coordinating action items with cross functional teams, tracking progress and ensuring timely completion of committed actions.

Supervision received :

This position is under the direct supervision of the Quality Compliance Manager. Works independently under general supervision, reviewed at project milestone and / or completion by senior management.

Essential Duties and Responsibilities :

• Owns and manages CAPA investigations and actions
• Provides CAPA process guidance to other CAPA owners
• Provides root cause analysis assistance
• Provides project management support for CAPA action items, including leading meetings and communications and tracking gating items and timelines
• Independently investigates, gathers data, and performs preliminary data analyses.
• Reports on Key Performance Indicators to adhere to process and prevent occurrence of any non-conformity relating to product, process, or system.
• Provides experienced quality assurance support to manufacturing, product development teams, procurement, and other functional areas.
• Promotes the use of customer preferred techniques for continuous improvement such as Lean, Six-Sigma, Poka-Yoke (Error Proofing), and Measure System Analysis.
• Keeps up with current and developing manufacturing and engineering trends that concern product quality.
• Undertakes special projects as required and contributes to continuous improvement activities.
• Supports and lead process improvement activities.
• Writes reports and presents progress at project meetings.
• Achieves goals within established budgets.
• Plans projects or subtasks so they may be tracked and presented.
• Attends various meetings and actions / communicates instructions and follow-ups.
• Independently determines approach for completion of assigned tasks.
• Communicates confidently and effectively with all levels of management, peers, and key stakeholders, including timely escalation of quality issues.

Desired Minimum Qualifications :

Disclaimer :

The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.

The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.

Salary Pay Range :

$71,300.00 - $97,750.00 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.

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.