Quality Manager - Monroe, United States - CSafe Global

Description

Job Description

Job Description

Exciting Opportunity for a Quality Manager in the Cutting-Edge Cold Chain Solutions Industry
Are you a passionate

Quality Manager

looking to make a significant impact in the rapidly evolving cold-chain solutions field? Join our dynamic team and contribute your expertise to revolutionize how we manage temperature-sensitive products worldwide.

Key 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 FDR 21CFR.

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.


Qualifications:
Bachelor's degree in technical or scientific field, Engineering degree. Advanced degree (Mechanical, Electrical or Reliability) preferred.
Experience with FDA and ISO quality standards, including several completed ISO audits and FDA inspections.
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.
Certified auditor for ISO 9001, 13485 and FDA Quality System Regulations.
Excellent verbal and written communication skills
Experience in Manufacturing environment
Must be able to travel 25%-35%.


Our Benefits Include:
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

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.

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