Customer Quality Engineer

International Permanent USD100,000 - USD125,000
  • Opportunity to join a fast growing Diagnostics Company
  • Extensive Growth Opportunity

About Our Client

My client works with diagnostics companies, CROs, central labs and clinical testing laboratories, providing them with tools and solutions that give them confidence in the performance of diagnostic instruments and quality and reliability of their data.

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

The key responsibilities of the Customer Quality Engineer are

  • Manage site validation activities encompassing equipment qualification, and software and process validations. Maintain Validation Master Plans. Provide support during product and process validations by guiding the team through IQ, OQ, and PQ stages of the validation process. Review, approve, author, and execute validation protocols and reports.
  • Manage site change order process to assess and appropriately document risk including impact to internal and customer-related processes. Coordinate with functional teams across multiple sites to ensure timely completion of change activities.
  • Work with Manufacturing Operations, QC, and Technical Support to evaluate production processes and monitor product quality performance. Collaboratively solve manufacturing and quality issues.
  • Investigate quality issues and trends from customer complaints, NCMRs, CAPAs, etc. to identify actions required

The Successful Applicant

The successful Customer Quality Engineer will have

  • Ability to interpret FDA QSR regulations as well as ISO 13485 and ISO 14971
  • Comprehensive validation experience including ability to guide prospective, concurrent, and retrospective studies
  • Knowledge of statistical methodologies, quality control and manufacturing operations
  • Ability to strategically evaluate and implement practical, timely resolution of non-conformances, deviations, customer complaints, and CAPAs
  • Intermediate to advanced computer skills with word-processing systems, spreadsheets, databases, ERP systems, and electronic quality management system software
  • Strong interpersonal, organizational, verbal and written communication skills
  • Demonstrates curiosity, adaptability and commitment; works best in a team environment and actively seeks to foster relationships
  • Focused on problem solving including problem definition, risk evaluation, and risk-based resolution

What's on Offer

My client offer a competitive Salary, Benefits, and PTO. The candidate will be required to be on-site full-time.

Contact
Daniel Hall
Quote job ref
JN-112021-4542430

Job summary

Sector
Engineering & Manufacturing
Sub Sector
Quality, Technical
Industry
Industrial / Manufacturing
Location
International
Contract Type
Permanent
Consultant name
Daniel Hall
Job Reference
JN-112021-4542430