Senior Quality Manager, CAPA & NC

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.

SUMMARY

The Senior Quality Manager CAPA and Nonconformances (NC) has responsibilities to develop and lead the implementation plan of Integras Global Quality Management System Compliance Processes (CAPA and Nonconformances). Work with process and Quality Operations leadership to drive consistent best practices for CAPA and NC Management Review and Metrics and establish global oversight. Deploy CAPA and NC processes and digital systems that improve compliance efficiencies and overall effectiveness. Responsible for partnering with global quality leaders to develop processes and metrics that result in attaining the companys improvement objectives and growth strategies.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully an individual must be able to perform each essential duty satisfactorily.

• Establish and maintain the Corporate CAPA board to address company-wide Corrective and Preventive actions. Includes the identification of issues their investigation and implementation of actions to address nonconformances and verification of the effectiveness of the actions.

• Maintain the Global Nonconformance (NC) process to ensure compliance in areas of investigation effectiveness timeliness quality and thoroughness of content. Collaborate with process owners and stakeholders in Corporate division and site to ensure the program is compliant executable and continuously improves.

• Lead the reporting of quality system performance metrics to be used at all levels of the organization (site division and corporate) collaborating with process owners and key stakeholders in corporate division and site. Ensure NC and CAPA metrics are appropriately cascaded through Management Reviews.

• Work closely with NC and CAPA owners to ensure timelines are met with high quality documentation.

• Standardize alert and action limits for escalations to senior leaders and other stakeholders

• Ensure key process indicators of NCs and CAPAs are integrated into Quality Management Reviews.

• Evaluate new regulations guidelines and industry standards and their impact on CAPA and NC activities; plan and effectively implement plans across the business to maintain compliance.

• All other duties and responsibilities as assigned

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge skill and/or ability required for his position.

Education:

• Bachelors degree is required preferably in a scientific or engineering discipline.

• 10 years of demonstrated quality experience in the medical product and device industry with strong concentration in US FDA QMSR and ISO 13485 compliance and quality assurance.

• Proficient understanding and demonstrated practical application of medical device regulations which include CAPA NC and Metrics.

Skills/Knowledge:

• Experience with communicating with domestic and international regulatory bodies.

• Strong analytical strategic decision making and risk assessment abilities.

• Ability to effectively collaborate with process owners and stakeholders in corporate division and site

• Highly developed technical writing and editing skills.

• Excellent organizational leadership and interpersonal skills.

• Proficient in the following computer software applications: Microsoft Office Copilot

• Exceptional interpersonal skills.

• Strong organizational and communication skills (written and verbal).

• Ability to travel domestically and internationally as business required.

• Experience in FDA regulated environment.

• Ability to interface with technical and non-technical personnel.

• Ability to utilize a computer telephone smart phone as well as other general office equipment. Strong computer skills are required.

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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