Quality Manager

About the role

A quality-focused leader with expertise in regulatory compliance and continuous improvement is needed to join our team as a Quality Manager. The successful candidate will lead the development, implementation, and oversight of our Quality Management System, ensuring compliance with various standards and driving quality excellence across the organization.

Responsibilities

• 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.
• Serves as supervisor of Quality Engineers and/or Technicians.
• Manages the quality of a network of 3rd party manufacturing and distribution locations.
• Manages Quality performance of our suppliers.

Requirements

• 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.
• 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 relevant 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 quality 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.

Benefits

At CSafe, we offer a range of benefits to our employees, including paid time off, medical, dental and vision insurance, a 401(k) with employer match, group life and disability insurance, health spending account options, identity protection, employee assistance program, travel assistance program, financial wellness program, tuition reimbursement, parental leave, referral program, gym membership reimbursement, and more. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.