Quality Systems Engineer

Industry

Engineering

Advert ID

FOX_BBBH66211

Location

Plymouth

Job Type

Permanent

Hours

Full-Time

Salary Range

Up to USD0.00 per year

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 has partnered with a growing medical device company that is now hiring for a Quality Systems Engineer to join their successful team.



You will work in an entrepreneurial and collaborative environment where innovation and creative thinking are highly valued. The company is focused on empowering employees, providing flexibility with accountability and plenty of opportunity for long-term career growth.



Summary:



The Quality Systems Engineer directly supports the implementation and maintenance of the Quality Management System (QMS). This role leads continuous improvement projects within the QMS to improve efficiency and effectiveness, participates in audits across all areas of the business and the supply chain. The Quality Systems Engineer maintains a strong collaborative partnership with cross-functional team members that facilitate organizational success by protecting patient/user safety and meeting business needs.



Responsibilities:



* Subject Matter Expert (SME) for the company Quality Management System (QMS).

* Supports the analysis of current and future QMS needs of the organization.

* Process champion for Change Control and Deviation QMS sub-systems.

* Manages Corrective and Preventive Action (CAPA) records from initial investigation and root cause analysis, into action planning in a timely and compliant manner.

* Initiates and executes audits, including developing and documenting audit plans, leading the audits, generating audit reports, and tracking subsequent actions.

* Provides training on the Quality Management System, including Current Good Manufacturing Practices (cGMP)

* Collaborates on User Requirements Specifications for eForms supporting the QMS within the eQMS software.

* Supports validation/verification activities for the use of software supporting the QMS.

* Reports on Key Performance Indicators (KPIs) to adhere to process and prevent occurrence of nonconformities related to the QMS.

* Leads the response teams for auditing nonconformances.

* Compiles and reviews batch record documentation supporting release of finished products.

* Generates trend reports, process performance reports and project reports.

* Performs duties in accordance with the Company's Quality Systems and with standard operations procedures (SOPs) that are consistent with regulatory requirements and industry standards.







Qualifications:



* Minimum of 2-year degree with 5+ years of related experience or 4-year degree with 3+ years of related experience.

* 3+ years of experience in quality management systems and regulatory compliance within the medical device industry.

* Strong knowledge of SOPs, GMP/FDA/ISO principles.

* Experience leading and supporting quality management system audits; internal, supplier, and external.

* Ability to find, manipulate and compile data related to deviations and CAPA's

* Extensive experience driving CAPA's to closure.

* Solid understanding of change control and deviation system management.

* Ability to lead monthly team meetings related to deviations and CAPA's

* Strong analytical and problem-solving skills to quickly identify root cause

* Demonstrated project management skills to plan, conduct and implement project deliverables

* Ability to effectively interface with department leaders and decision makers at all levels.

* Experience working on finished product releases a plus.

* ASQ CQA Certification a plus.