DQA Manager

Hudson Permanent USD120,000 - USD140,000
  • Design Quality Leadership Opportunity with Industry Leading Laser Tech Company
  • Terrific Work From Home Flexibility

About Our Client

My client is an industry leader in Medical Laser Technology. They have been fast growing over the past few years and have a plethora of new products in their pipeline.

Job Description

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.

Description

Responsibilities for the Design Quality Manager Opening are

  • Work on MDR project team to bring current designs up to newly required compliance requirements.
  • Responsible for Review and Approval of protocols and reports, SOPs and Master Documents pertaining to Research and Development activities and it's compliance.
  • Responsible to provide Quality support at various stages of Product Development.
  • Responsible for the co-ordination with internal and external customer and R&D team to resolve Development related product quality issues.
  • Responsible for review of Product Development Reports and relevant data.
  • Coordinate and support for release of Pilot batches for studies.
  • Insure FDA and other regulatory knowledge and experience is applied to risk assessments
  • Work with manufacturing engineering to ensure necessary process controls are in place for design changes.
  • Act as an effective team member in the execution of Quality functions in compliance with FDA QSRs (Design Control, CAPA, etc.), ISO 13485 and other national and international quality and regulatory requirements and standards
  • Contribute to the design, development and implementation of product assurance plans providing feedback to corrective and preventative actions to engineering, manufacturing, service and field operations and supplier performance

The Successful Applicant

The successful Design Quality Manager will

  • Bachelor's degree in Engineering or related field, plus a minimum of 5 years of related experience in the medical device or another regulated industry
  • Expert understanding of appropriate global medical device regulations, requirements and standards, including Quality Management System (ISO 13485) and Medical Device Regulations (21 CFR 820) is a must
  • Project Management (development of project plans, status meetings, project reporting, etc.) and organizational change movement
  • Ability to analyze information and come to conclusions based on presented data

What's on Offer

My client offer a competitive base salary and benefits. They also will have flexibility to allow the Design Quality Assurance manager to Work from Home. Further details will be given during discussion.

Contact
Daniel Hall
Quote job ref
JN-012022-4566443

Job summary

Sector
Engineering & Manufacturing
Sub Sector
Quality, Technical
Industry
Healthcare / Pharmaceutical
Location
Hudson
Contract Type
Permanent
Consultant name
Daniel Hall
Job Reference
JN-012022-4566443