Senior Quality Engineer II

Industry

Engineering

Advert ID

FOX_BBBH189146

Location

Plymouth

Job Type

Permanent

Hours

Full-Time

Salary Range

Based on Experience

No. of Openings

1

Branch Information

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

ContactNumber

612-630-1200

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.



SUMMARY:



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.



RESPONSIBILITIES:



* 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.



QUALIFICATIONS:



* 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



HIGHLY DESIRABLE:



* ASQ Lead Auditor Certification

* ASQ CQE Certification

* Six Sigma Green/Blac Belt Certification