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QA CAPA Manager

3 months ago

Santa Barbara, California, United States KARL STORZ SE & Co. KG Full time
Every day our products and services help to save lives
around the globe. Therefore, we make quality and
reliability our number one priority.
Get to know us and join our team as
QA CAPA Manager

Job Function:
Patient Health & Regulatory Affairs

Location:
Goleta, CA, US, 93117

Stafford, TX, US, 77477

Charlton, MA, US, 01507

Work Flexibility:
Onsite (Office/ Production)
KARL STORZ United States is currently recruiting a

CAPA Manager


who will be responsible for supporting the development, deployment, maintenance, and improvement of the Corrective Action and Preventive Action (CAPA) Management processes and procedures within the KARL STORZ (KS) organization.

This role will ensure effective deployment of CAPA requirements (both internal and external) into the division and corporate procedures, provide leadership and/or represent Quality Affairs corporate improvement teams focused on CAPA Management and ensure conformance to global quality management regulations, KS quality policies and standards, and key performance indicators.

This is an onsite role and can be based in Goleta, CA, Stafford, TX or Charlton, MA.
Responsibilities
Facilitate root cause investigations and developing corrective and preventive measures.
Carry out the effectiveness controls.
Monitor and track measures and CAPA phases.
Ensure complete and adequate documentation of the CAPA.
Manage and moderate CAPA team meetings.
Provide guidance and direction of the CAPA systems Body-of-Knowledge.

Provide subject matter expertise, leadership, and training on investigational & Root Cause Analysis techniques, as appropriate, to other CAPA team members and to technical subject matter experts involved in the resolution of quality issues.

Support audits and regulatory inspections US location as a global CAPA subject matter expert.

Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.

Maintain the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.

Ensure all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.
Produce and analyze trend metrics & reports and establish further actions, as required.
Represent the CAPA organization on interdivisional committees to drive continues improvement across the corporation.
This position will serve as a functional representative for organizational initiatives potentially impacting or affecting the QMS.
Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
Manage the execution of goals.
Accountable to the Quality Organization for achieving mutually agreed upon objectives.
Position involves interactions across multiple functional areas including operations, R&D, Marketing, Supply Chain, Quality, and Regulatory.

Decisions and recommendations made by this position directly influence and impact the quality of marketed products and the effectiveness of KARL STORZ's Quality System to applicable regulations.

Requirements
Bachelor's Degree or other qualifying experience
5+ years working in a quality management system environment, with direct experience working with CAPAs in a regulated environment.
Experience in auditing quality management systems ( ISO 9001 or ISO 13485)
EU Directives, particularly European Medical Device Regulations
EN ISO 9001, ISO 13485, Quality System standards
FDA Quality System Regulation 21 CFR Part 820 and other related FDA regulations
European Union Medical Device Regulation
Knowledge of standards and laws applicable to medical devices, such as ISO 13485, 21 CFR Part 820
Knowledge of Statistics
Proficiency in MS Office; working knowledge of Tableau a plus
Leading cross-functional teams to accomplish goals and objectives.
Demonstrated experience in root cause analysis, critical thinking, and problem solving methodologies
Excellent written and spoken communication
Ability to reliably work independently
Hands-on mentality
Develop and maintain productive and effective relationships with regulatory authorities and coworkers.
Ability to work constructively and cooperatively with employees at all levels in the organization.
Effective leadership in a multi-disciplined team setting through communication, education, and mentoring.
Ability to travel approx. 10-25%
Ability to lift, on occasion, approximately 20lbs.
Preferences
Master's Degree in Technical Field or Quality
Six Sigma Certification
Certificate of completion in lead auditor training for ISO 9001 or ISO 13485
7+ years' experience in quality management in the medical technology or pharmaceutical industry. Ideally in the areas of Measurement, Analysis, Continuous Improvement, CAPA, Quality Systems.
2+ years team leading, supervising, or project management.
#LI-CW1
Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too*Up to 8 weeks of 100% paid company parental leave**401(k) retirement savings plan providing a match of 60% of the employee's first 6% contribution (up to IRS limits)
Section 125 Flexible Spending Accounts
Life, STD, LTD & LTC Insurance
We prepay your tuition up to $5,250 per year - Tuition pre-imbursement
Fitness reimbursement of up to $200 annually
Employee referral program of up to $2,000 per hire
And much more
*Field sales, internships, and part-time employees are not eligible except where required by state law.
Non-employees, including temporary workers and consultants, are not eligible to participate in the KARL STORZ benefits program.
**To include, maternal/paternal leave, adoption, and fostering of a child.

KARL STORZ reserves the right to change or modify the employee's job description whether orally or in writing, at any time during the employment relationship.

Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor.

Employees must comply will all applicable KARL STORZ policies and procedures.
KARL STORZ is committed to maintaining a safe work environment for our employees and customers. Most field-based roles at KARL STORZ require hospital credentialing/health screens as acondition of employment. Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers.

During the interview process, we encourage you to askhow credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.


Nearest Major Market:
Santa Barbara

Nearest Secondary Market:
Santa Maria

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