QA - CAPA Specialist

CAPA 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. 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

Bachelors in an engineering discipline recommended with minimum of 3 years' experience in the medical device or pharmaceutical industry; strong analytical skills, exceptional writing and interpersonal relationship skills or combination of relevant work experience and education. Previous CAPA and / or quality systems / assurance experience and demonstrated use of quality tools / methodologies. Detailed knowledge of FDA Quality Systems Regulations, GMP, ISO 13485 and other global regulations and standards. Previous experience in high volume manufacturing environment. (Medical Device preferred) Demonstrated project management and leadership skills, including the ability to lead cross-functional project teams and resolve quality related issues in a timely and effective manner. Strong verbal and written communication skills with the ability to communicate effectively at multiple levels of the organization. Demonstrated organizational skills with the ability to multitask, prioritize and meet deadlines. Must be able to read and write in English.

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. 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 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.