Corporate Quality Engineer (Direct Hire) Full Time

Corporate Quality Engineer

Dayton, OH 45424, United State

Duration: Direct hire

Pay rate: 110K -120K

Location Note: Onsite, with some flexibility for remote work

Interview Process:  1- initial video-meeting with hiring manager and team member. 2 – interview prior to offer with team members and peer managers

Key Skills: (Must Haves)

• All qualified candidates should have electronics manufacturing industry experience
• 5 plus years’ experience within a corporate quality management role with focus on Corporate Regulatory and Site Internal Audit and Supplier Audit programs
• Knowledge of ISO 9000, ISO 14000, ISO 16469, 27001 and ISO 13485 is required. Knowledge of CAPA system applications is required.
• Able to work with diverse teams and excel within a dynamic organization with evolving structure and fast paced growth
• Should have schedule flexibility to meet the challenges of a global organization, will be working regularly with teams located around the world (Travel may be 20% annually)

Company Overview:

Company is an exciting, entrepreneurial company, with a history of exceptional growth coupled with a disciplined and strategic focus on being the best. While GPS is at our core, we have grown beyond this technology to embrace other sophisticated positioning technologies and, in doing so; we are changing the way the world works. Our solutions are used in over 140 countries and we have incredibly diverse lines of business.

Our employees represent this diversity and can be found in over 30 countries, working closely with their colleagues around the world. Due to our geographic, product and customer reach, there is plenty of room at company for exceptional people to grow. Come position yourself with an innovative industry leader and position yourself for success.

Key Responsibilities:

Lead and drive the effort of defining the company’s Corporate Regulatory and Site Internal Audit and Supplier Audit programs through the implementation of harmonized and centralized processes and templates, provides direction for process improvement tools to ensure the process requirements of Quality Compliance systems are integrated.

Responsible for establishing and maintaining programs for the ongoing monitoring and improvement of the effectiveness of the Quality System & responsible for the creation, deployment, and maintenance of the internal audit schedule as well as status updates and reporting on resource or schedule adherence challenges.

Escalates key issues to upper management as appropriate.

Develop and maintain a Certification/Qualification program for internal auditors.

Provide leadership and coaching to the audit team for the implementation of regulatory, quality and quality system effectiveness audits company’s facilities and suppliers.

Develop, schedule and implement plans for comprehensive annual regulatory compliance audits taking into consideration quality metrics, results of site internal audits and external inspections, industry trends and the external regulatory environment.

Provide quality engineering guidance and support to the Corrective and Preventive Action (CAPA) process.

The Quality Engineer will collaborate with representatives from other functional areas to facilitate timely and effective Corrective and Preventive Action (CAPA) investigations, action plan implementation and effectiveness monitoring.

Work on complex investigations and will coordinate technical teams to ensure sound experimental design, effective data analysis, identification, implementation, verification and validation of CAPA actions.

Monitor vendor performance and establish criteria and rating system for critical vendors.

Improve quality performance of suppliers by conducting workshops at supplier locations, providing technical assistance in developing a quality system, using statistical techniques to define and resolve quality problems.

Skills & Experience Required:

Minimum of a Bachelor’s degree in a technical discipline (Math, Science, Engineering or Information Technology) is required; A degree is Engineering is preferred.

Minimum of 5 years work experience is required. Specific experience in corrective and preventive action efforts is required.

Working knowledge of ISO 9000, ISO 14000, ISO 16469, 27001 and ISO 13485 is required. Knowledge of CAPA system applications is required.

A demonstrated proficiency in process improvement methodology and use of investigative tools (Cause and Effect Diagrams, Trend Analysis, Capability Analysis, Control Charts, Pareto Charting, etc.)

This position requires the ability to effectively prioritize and manage multiple activities and responsibilities. Hands-on experience with Risk Assessment (especially Hazard Analysis, Fault Tree Analysis, DFMEA, PFMEA), Reliability Engineering and/or Product/Process Validation are preferred.

Ability to travel approximately 5 – 30% of time for company & supplier visits

#CB

Rate/Salary: 110K -120K