Senior Quality Systems Specialist

Trelleborg Group•Paso Robles, CA

49d•$70,000 - $85,000•Onsite

About The Position

Imagine working for one of the leading contract manufacturers in the world, nestled just 30 miles from California's stunning Central Coast. At Trelleborg Medical Solutions, we are not just a premier manufacturer of life-saving medical components; we are a forward-thinking company committed to excellence and innovation. Our journey in lean manufacturing has been ongoing for years, and we are on the path to becoming a showcase of excellence in the medical industry. Seize this rare opportunity to be part of a medical solutions business with over 100 years of history, all while enjoying the benefits of living in one of California's most desired locations! Trelleborg Medical Solutions is currently accepting application for a Senior Quality Systems Specialist (QSS). The Senior QSS is focused on the maintenance of the Quality Management System (QMS) to ensure compliance with regulatory, quality, company policies and manufacturing requirements.

Requirements

Minimum of 2 year degree in Quality, Regulatory, Manufacturing or related field; OR certificate in Regulatory Science or Medical Product Development plus 1 year of regulated industry work experience
3+ years of quality/regulatory experience in medical device or related industry
2+ year experience conducting investigations and root cause analysis for complex/advanced issues

Nice To Haves

4 year degree in Quality, Regulatory, Manufacturing or related field
ISO13485:2016 and/or ISO9001:2015 Auditor Certification
Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable)

Responsibilities

Supports all aspects of the internal audit program, ISO notified body audits, customer audits and FDA inspections, including but not limited to: Serve as an auditor for internal audits Create and maintain internal audit schedule Audit controlled document files in preparation for regulatory inspections and provides support during regulatory inspections and client audits Initiate and execute audits, including developing and documenting the audit plan, leading the audit, generating the audit report, and tracking subsequent actions with the team Provide support during external audits including scheduling, hosting, preparing audit responses Work with subject matter experts to ensure audit record content is accurate, well documented, and meets the requirement of the process
Develops metrics and performs trend analysis of key QS areas such internal and external audit findings, CAPAs, nonconforming material, training, deviations, etc. to identify areas for improvement. Escalates trends to an appropriate quality system such as CAPA or CI; presents analysis to management
Supports maintenance of the CAPA program
Serves as CAPA Owner as needed, driving necessary investigation, correction, and corrective/preventive actions
Ensures all internal and external audit findings are entered into the CAPA system, assigned to the appropriate personnel, and are completed in accordance to the CAPA procedures, within specified time periods
Approve corrective action plans and verify effective and timely implementation of corrective actions for audit nonconformities
Oversees completion and control of customer questionnaires and other customer-required documents
Initiates, facilitates and/or manages projects to expand, change, enhance and improve the quality system, as assigned
Supports and coordinates activities related to nonconforming material, complaint/customer feedback, deviations, RMA, and CAPA processes
Provides quality system training for the organization as needed
Manages review of documents to ensure ISO/FDA compliance of controlled documents lifecycle including annual review management
Own or co-lead strategic quality initiatives, such as QMS harmonization, digital transformation, or audit program redesign.
Communicate quality system changes effectively across the organization, ensuring understanding and adoption
Own or support projects and associated activities to ensure ongoing compliance as related to QMS.
Design and deliver targeted training programs based on audit findings, CAPAs trends, or regulatory updates.
Mentor and train junior QS Specialists, auditors, and CAPA owners.
Own complex CAPAs or systemic issues that require cross-departmental or cross-site coordination.
Perform deep-dive trend analysis across multiple quality subsystems and present findings to senior leadership. Recommend strategic actions based on data insights (e.g., training needs, process changes, risk mitigation).
Develop and implement enhancements to the QMS based on audit trends, CAPA effectiveness, and regulatory changes.