Job Information
Integra LifeSciences Senior CAPA Engineer in US, Ireland
Changing lives. Building Careers.
Joining us is a chance for you 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, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
SUMMARY DESCRIPTION
The Sr CAPA and NC Quality Engineer is responsible to coordinate CAPAs, NCs and metrics gathering in support of Integra’s corporate CAPA program. This Quality Engineer will work with CAPA owners to conduct root cause investigations and develop action plans and effectiveness checks. This individual will also work with the Sr. Manager of CAPA, NC and Metrics to ensure that performance metrics assessing the health of the corporate quality system are collected and analyzed per schedules. The individual must possess the ability to establish and maintain effective working relationships with Integra QA, RA and Operations Team members worldwide.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Facilitate the tracking and closure of Corporate CAPAs addressing company-wide Corrective and Preventive actions.
Facilitates and works with CAPA owners to support the identification of issues, investigations, root cause analysis, action plan development and completion, and verification of the effectiveness
Facilitate the tracking and closure of corporate Nonconformances (NCs) to ensure consistency in compliance in areas of evaluation, risk, corrections, timeliness, quality and thoroughness of content.
Coordinates across cross-functional CAPA / NC teams and ensures compliant and appropriate documentation of CAPA and NC activities from owners
Support Sr. Manager CAPA and Metrics by contributing to process improvements, innovative solutions, and training to standardize processes globally and to meet the changing regulatory compliance environment and compliance goals while minimizing complexity of implementation for Integra organizations
Facilitate quality metrics gathering, analyzing and reporting on a regular and ad hoc basis.Support the development and rollout of standardized QMS data sources and metrics across all levels of the organization (site, division and corporate) for input into NC / CAPA or for assessment of key quality system processes
Maintain current knowledge of FDA and any other applicable international Quality System regulations for medical devices and human tissue products.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill and/or ability required for his position.
Bachelor’s Degree in Life Sciences, Technical or Engineering
Two (2) years in a regulated industry (medical device, pharmaceutical or diagnostics) in a compliance role minimum; 3-6 years preferred
Computer skills to include knowledge and experience using Microsoft Office (or equivalent), Teams, Sharepoint and proficient use of contact sources for regulations and compliance on the worldwide web network. TrackWise use a plus.
Experience with root cause analysis and problem-solving methodologies. Strong analytical and organizational skills.
Excellent written and oral communication skills
Ability to review and analyze documentation required critically and logically.
In an effort to minimize the spread of the coronavirus and to protect our employees, all new hires in the US and Puerto Rico will need to be fully vaccinated for COVID-19 in order to be considered for employment with Integra LifeSciences, unless eligible for an accommodation as provided by law.
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.
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