Senior Quality Engineer II



Advert ID




Job Type




Salary Range

Based on Experience

No. of Openings


Branch Information

Minnesota Engineering - (USA) 3600 Minnesota Drive Suite 850 MN Edina , MN 55435



Job Description

Manpower Engineering is working with a leading specialty medical-device company that combines their drug development expertise, proprietary delivery technology, and innovative device design to provide safe and effective medicinal treatments to patients across the globe. As a result of continued growth, the company is seeking a Senior Quality Engineer II to join their talented team.


The Senior Quality Engineer II leads quality engineering activities for commercial products, including process validation, maintenance of DMR and risk management files, complaint risk analysis, and CAPA/SCAR/Deviation investigations. This position also participates in quality engineering activities for commercial scale up prior to product launch and supports internal and contract manufacturing.


* Evaluates mechanical product design and identifies potential design quality issues and drives technical decisions

* Drives design quality, reliability, and compliance to standards and regulations

* Maintains risk management files for commercial products via periodic review of risk documents, complaints and nonconformance trends

* Supports DMR content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps

* Supports manufacturing process development & qualification for product changes

* Maintains release testing plans and associated test methods and procedures

* Identifies and leads continuous improvement projects

* Leads CAPA/NCR/SCAR investigations and reports

* Supports internal & external audit

* Leads complaint investigations

* Leads quality system improvements as required

* Reviews supplier documentation in accordance with established requirements

* Responsible for maintaining a strong collaborative partnership with cross-functional team members and customers that facilitates organizational success by protecting patient/user safety and meeting business needs.


* Bachelor level degree in Engineering (Mechanical, Material Science or Biomedical) or related Science

* 7 - 10 years relevant experience within the medical device industry or related function

* Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance

* Background in supplier quality

* Experience working for a medical device OEM

* Experience in process validation

* Strong statistical data analysis skills

* Ability to manage multiple projects simultaneously

* Excellent verbal and written communication skills

* Ability to educate stakeholders, customers and management at all levels

* Ability to interface with internal customers, 3rd-party partners, Health care providers (HCPs) and regulatory agencies

* Experienced participating in quality audits


* ASQ Lead Auditor Certification

* ASQ CQE Certification

* Six Sigma Green/Blac Belt Certification