Essential Functions & Duties - Management Representative of the Quality Management System; develop, improve, and implement key quality system processes to ensure compliance with ISO 9001, ISO 13485, CE, TGA, and FDA 21 CFR 820.
- Person Responsible for Regulatory Compliance (PRRC) for medical devices, ensuring device conformity to the quality management system and harmonized standards.
- Ensures development, communication, implementation & maintenance of best-in-class quality management tools & principles.
- Promotes continuous improvement.
- Defines, communicates, and gains cross-functional support for the site's Quality System and compliance strategy to mitigate product and compliance risk.
- Designs and implements effective quality processes including procedures, doc systems, CAPA, complaints, tools, reporting metrics and measurable improvements that are required to meet quality system standards and customer requirements.
- Interface with customers, suppliers, and agencies as necessary.
- Supervision of Quality Engineers and/or Technicians.
- Manage the quality of a network of 3rd party manufacturing and distribution locations.
- Manages Quality performance of our suppliers.
Knowledge, Skills & Abilities - Thorough knowledge of Quality tools (such as, but not limited to DOE, design of sampling plans, SPC, failure analysis, FMEA, DFMEA, etc.)
- Strong interpersonal skills, both written and verbal.
- Must possess analytical thinking and reasoning skills.
- Must be thorough and exercise attention to detail.
- Must be able to set and maintain schedules.
- Must have good supervisory and mentoring skills.
Preferred certified auditor for ISO 9001, 13485 and FDA Quality System Regulations.
Education & Experience- Bachelor's degree in technical or scientific field, Engineering degree.
- Advanced degree (Mechanical, Electrical, or Reliability) preferred.
- Experience with FDA or ISO quality standards, including several completed ISO audits and FDA inspections.
- 5 plus years' experience in Quality System and Compliance environment with at least 5 years in a managerial role.
- Education/experience in one of the following:
- a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent in law, medicine, pharmacy, engineering or another relevent scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.
- four years of professional experience in regulatory affairs or in quaity management systems relating to medical devices
- Experience in medical device manufacturing, preferably a class II device.
- Experience with FDA and ISO quality standards, including several completed ISO audits and FDA inspections.
Why Join Us?At CSafe, we foster an exciting, collaborative, and inclusive work environment that promotes both personal and professional growth. Here's what we offer to our employees:
- Paid Time OFF (PTO) starting at 25 days & Paid Holidays
- Medical, Dental and Vision Insurance
- 401k with Employer Match
- Group Life & Disability
- Health Spending Account Options
- Identity Protection
- Employee Assistance Program
- Travel Assistance Program
- Financial Wellness Program
- Tuition Reimbursement
- Parental Leave
- Referral Program
- Gym Membership Reimbursement
