Quality Systems Engineer

2 weeks ago

Bethel, United States People*Strata Full time

This position employs an individual skilled in advanced quality assurance techniques with an in-depth understand of the ISO 13485 Quality standard. Areas of focus include but are not limited to: statistical process control, performance metrics, customer management, ISO, FDA, and GMP compliance. This position will focus primarily on improving quality systems infrastructure in a contract manufacturing environment. Additionally, this individual will also be responsible for the maintenance and improvement of the Resonetics ISO certified Quality System. There will be a concentration on customer related and internal process related activities including surveys and audits.

Responsibilities

Partner to establish, document and maintain all Quality Assurance policies and procedures across all Resonetics locations. This includes upkeep of the Resonetics Quality Manual and supporting procedures.
•Liaising with customer quality personnel to resolve issues and customer complaints.
•Partner with appropriate parties to resolve corrective and preventative actions.
•Assist with customer and regulatory audits.
•Take ownership of assigned production readiness activities to ensure that quality awareness is inherent in process development.
•Develop and assist with development of standard operating procedures, including solicitation of functional department input and participation in process development.
•Lead quality improvement initiatives across multiple sites and report on the progress.
•Conduct weekly/monthly reporting of activities and key metrics.
•Customer liaison for quality system related issues. May assume project manager role for specific customer applications.
•Train Resonetics employees on quality principles and procedures.
•Administer and improve Resonetics' quality management system, including its quality

Qualifications
•Minimum 3 years' experience in a Quality Systems role.
•Demonstrated background in an ISO 9001 or ISO 13485 or comparable quality and regulatory system.
•Strong writing skills.
•Bachelor's degree in a technical discipline or equivalent experience

Preferred Qualifications
•Experience with Quality Information Systems software, preferably QCBD.
•Certified Lead Auditor
•ASQ certified Quality Engineer and/or Manager of Quality and Operational Excellence

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