Quality Manager

CSafe Global; Monroe (OH); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Paid Time Off 25 days + Holidays

Medical, Dental and Vision Insurance

401k with Employer Match

Group Life & Disability

Tuition Reimbursement

Parental Leave

Gym Membership Reimbursement

Job summary

CSafe Global, based in Ohio, seeks a Quality Manager to lead the Quality Management System, ensuring FDA, ISO 9001, ISO 13485, CE compliance and driving continuous improvement across manufacturing, engineering and supply chain.

You will oversee PRRC responsibilities for medical devices, supervise QA engineers, implement CAPA and supplier quality programs, and elevate the overall quality maturity of the organization.

Qualifications

• Bachelor's degree in engineering or sciences.
• Experience with FDA/ISO quality standards and multiple ISO audits and FDA inspections.
• 5+ years in Quality System and Compliance with managerial experience.

Responsibilities

• Management Representative of QMS; develop, improve and implement quality processes to meet standards (ISO 9001, 13485, CE, FDA).
• Regulatory Compliance (PRRC) for medical devices; ensure conformity with requirements.
• Develop and maintain quality tools, CAPA, complaints handling, metrics and continuous improvements.
• Interface with customers, suppliers and regulatory agencies as needed.
• Supervise Quality Engineers/Technicians and manage supplier quality performance.

Skills

DOE

SPC

FMEA

DFMEA

Regulatory Knowledge

Leadership

Education

Engineering degree

Advanced degree preferred (Mechanical/Electrical/Reliability)

Job description

Job Description

Exciting Opportunity for a Quality Manager in the Cutting-Edge Cold Chain Solutions Industry!Are you a quality-focused leader with expertise in regulatory compliance and continuous improvement? Join our team as a Quality Manager and lead the development, implementation, and oversight of our Quality Management System. In this high-impact role, you will ensure compliance with FDA, ISO 9001, ISO 13485, CE, and other applicable standards, while partnering with Manufacturing, Engineering, Supply Chain, and Regulatory teams to drive quality excellence across the organization. This is an opportunity to lead a talented team, influence strategic quality initiatives, and make a meaningful contribution to the success of our products and customers.

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 FDA21 CFR820.
• 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?

• 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

An Equal Opportunity Employer. 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.