QA - CAPA Specialist

Integra LifeSciences Holdings Corp.•Mansfield, OH

67d

About The Position

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.

Requirements

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.
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.

Nice To Haves

Previous experience in high volume manufacturing environment. (Medical Device preferred)

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.