QA 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 whats 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 CAPAs 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.

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:

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 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.

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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 candidates 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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