Quality Systems Specialist I.

Responsibilities

• Assist Quality Systems management to manage global CAPA system and drive continuous improvements.
• Schedule and manage HQ for CAPA; Record all meeting notes and actions;
• Manage CAPA database : Update CAR status and reporting agenda; Follow up with pending CARs;
• Assist internal audit activities per ISO 13485, 21CFR820, MDR and MDSAP and other applicable QMS requirements.
• Audit the quality system on a periodic basis to verify compliance.
• Track and support completion of all action items resulting from internal audits.
• Schedule and organize Manage Review activities.
• Assist QMS management to coordinate global QMS activities and support needs from all Starkey facilities.
• Host regulatory global QMS meetings and activities.
• Drive actions to establish and maintain unified global QMS system.
• Provide education, verification and maintenance for the ISO 13485.
• Coordinate educational / informational meetings with managers and supervisors.
• Ensure and verify that all internal and external requirements are being completed on time and in compliance with guidelines.
• Provide up-to-date information to proper personnel on regulatory changes to ensure that requirements are met.
• Comply with FDA 21CFR820 rules, regulations and guidelines.
• Maintain GMP’s (Good Manufacturing Practices) according to FDA guidelines.
• Verify compliance with regulations by regularly monitoring internal system.
• Assist FDA investigators with information collection and interpretation during FDA audits.
• Maintain required approvals, facility registrations and export certificates.
• Support new product development and homologation activities.
• Support the development of regulatory requirements, manage documents and records, and coordinate required testing.

JOB REQUIREMENTS

Minimum Education, Certification and Experience Requirements

• Education
• Four-year degree required. Education in Engineering or Science preferred. Master’s degree (MS, MBA) preferred.
• Experience
• Quality Systems Specialist I : Minimum 3-5 years’ experience in related field required.

Knowledge / Technical Requirements

• Knowledge of GMP and FDA 21CFR820 required.
• Knowledge of MDR required.
• Knowledge of ISO 13485 criteria required.
• Familiarity with production functions required.

Competencies, Skills & Abilities

• Ability to lead group meetings / presentations required.
• Previous experience working within a Quality System (Medical Device or Pharmaceutical)
• Critical thinking and problem solving
• Good attention to detail

WORK CONTEXT

Working Conditions

Normal office conditions

Equipment Operation

• Normal office equipment
30+ days ago