Quality Manager

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Quality Manager

Monroe, OH

Organization: CSafe

Salary: based on experience

THE OPPORTUNITY

  • Do you excel in leading cross-functional teams to drive continuous improvement initiatives?
  • Are you committed to developing and maintaining best-in-class quality management tools and principles?
  • Are you skilled in interfacing with customers, suppliers, and regulatory agencies to uphold quality standards?
  • Does working a hybrid schedule appeal to you?

 

ABOUT THE COMPANY

CSafe offers the most comprehensive suite of thermal shipping solutions for pharmaceutical cold chain shipping needs around the world to ensure patients receive the medicines and treatments they need. With a “patient-centered” focus, deep industry expertise and commitment to innovation, CSafe continues to deliver industry-leading products in both the active and passive segments. CSafe is the only provider with an end-to-end portfolio including active and passive bulk air cargo, parcel, cell and gene and specialty last-mile use cases allowing their team to match customer requirements to the best solution for their needs. Any size, any duration and any temperature – CSafe is at the heart of the cold chain.

 

WHAT YOU’LL BE DOING

Reporting to the VP of Global Quality, you will join a dynamic team and contribute your expertise to revolutionize how CSafe manages temperature-sensitive products worldwide. As the Quality Manager, you will lead a team of three and have the following primary 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.
  • Accountable 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.

 

IDEAL CANDIDATE QUALIFICATIONS AND EXPERIENCE

  • Bachelor’s degree in engineering or other technical or scientific field. Advanced degree (Mechanical, Electrical or Reliability) preferred.
  • 10+ years of experience in a manufacturing or product development environment 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.)
  • Supervisory/management experience with strong mentoring skills.
  • Certified auditor for ISO 9001, 13485 and FDA Quality System Regulations.
  • Experience with ERP/MRP system.

 

KEY PERSONAL ATTRIBUTES

  • Strong interpersonal skills with excellent verbal and written communication skills
  • Analytical thinking and reasoning skills
  • Thorough with strong attention to detail
  • Ability to set and maintain schedules
  • Must have good supervisory and mentoring skills
  • Must be able to travel 25-30%

 

THE PAYOFF

This is an outstanding opportunity to work for a very successful, growing organization that is extremely reputable in the industry with the opportunity for continued career growth. CSafe provides a hybrid work schedule and excellent benefits, including a generous PTO policy.

 

DIVERSITY/INCLUSION STATEMENT

Gilman Partners is committed to strengthening leadership teams and elevating the talent in our communities – and that means all qualified applicants will receive consideration without regard to race, ability, religion, sex, age, sexual orientation, gender identity/expression, or national origin. You don’t have to meet every qualification in this job description to apply. If you’re drawn to the position and believe your experience makes you a good fit, we encourage you to reach out.