Quality Manager

Des Plaines Permanent USD105,000 - USD130,000
  • Report to VP of Quality
  • Lead Quality Department and build your own team

About Our Client

Our client is a global strategic manufacturing partner that helps medical device OEMs bring complex medical devices and components to market. A supplier and distributor of medical devices and instruments to OEMs and hospitals.

Job Description

  • Position reports to VP of Quality Assurance and Regulatory Affairs
  • Provide strategic leadership on all regulatory affairs and quality assurance programs and policies; strengthen and continually improve company-wide level of internal and external quality.
  • Lead quality assurance department in the design, provision, and maintenance of systems for document and data change control, training, corrective and preventive action, discrepancy handling, product release, environmental monitoring, and complaint handling.
  • Provide consultation to all departments on application of quality and regulatory requirements.
  • Develop and maintain quality system procedures for quality and regulatory department responsibilities.
  • Lead quality assurance and regulatory affairs functional review and approval of quality system documentation.
  • Manage quality engineering support function; indirect support to quality inspection teams who report to quality engineering.
  • Work in a close, collaborative fashion with management in the pursuit of adherence to documented processes and the development of key performance indicators.
  • Interact with customers and suppliers on all quality matters while building and maintaining strong relationships.
  • Directs the selection, training, and development of personnel within the limits of company administration policy.
  • Essential Functions:
  • Coach, mentor, develop, direct, train, and evaluate the work of quality improvement personnel.
  • Maintain a robust Quality Management System that meets all FDA, ISO 13485 and customer requirements.
  • Ensure customer satisfaction with product quality.
  • Receive and provide communications and related materials and reports regarding parts revisions, parts on hold, questions on dimensions, parts rejections, parts changes, qualifications, validations, internal audit data, and other quality-related information the customer requires.
  • Receive, interpret, and implement corrective action procedures for product quality that the customer requires.
  • Implement changes in the process/procedures requirements to improve product quality.
  • Oversee the internal/external audits and CAPA programs.



MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

  • Bachelors Degree in engineering or technical field
  • 5+ years of experience in quality and manufacturing; preferred 2+ years of management experience
  • Medical Device (ISO 13485 and FDA) experience
  • Knowledge of managing company QMS, SPC, GMP
  • Possess strong written, oral, and mathematical skills

What's on Offer

  • $105,000-$130,000 Salary Range
  • Offers a competitive bonus of 10%
  • Benefits package includes: dental, vision, health, short and long term life
  • 3 Weeks PTO, 5 Sick Days
Contact
Bryant Martin
Quote job ref
JN-042022-5432751

Job summary

Sector
Engineering & Manufacturing
Sub Sector
Engineering Design and R&D
Industry
Healthcare / Pharmaceutical
Location
Des Plaines
Contract Type
Permanent
Consultant name
Bryant Martin
Job Reference
JN-042022-5432751