Senior Engineer, Quality Assurance Engineering

4 weeks ago

Solon, United States Rose International Full time

Major Duties and Responsibilities:

Responsible for overall service quality management of the site.

Responsible for the quality system of the site including maintaining compliance to regulatory requirements and certifications (ISO 13485) and supporting audits.

Initiate and complete change cycle for updated QMS documents including change implementation and training.

Engage and interface in internal and external audits providing subject matter expertise.

Act as internal Auditor of client QMS

Work closely with business functions to ensure compliance and high-quality performance of Service processes.

Engage in the development and improvement of Service processes for existing products.

Support day to day service operations and addressing line requests by acting as Subject Matter Expert for Quality and Manufacturing standards.

Support the creation and maintenance of service procedures for incoming analysis, trouble shooting, repair, and inspection of products returned from customer.

Own, maintain and improve Service line(s) layout, setup, configuration, and fixturing.

Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.

Support continuous improvement initiatives with suppliers and in-house teams to improve Quality, reduce cost, and increase efficiency and effectiveness of Service processes.

Collaborates with cross functional teams and suppliers to address quality issues and align practices.

Support analysis and resolution of Service-related complaints and field actions

Own internal and supplier non-conformances and manage the timely disposition and closure of NCRs/NCs

Communicate/collaborate with suppliers regarding non-conformances, escalating supplier corrective actions requested as required.

Own or support identified internal CAPAs and manage to timely root cause investigation, implementation, and closure.

Assess and implement internal and supplier proposed changes. Performs PPAP activities for supplier changes.

Plan and execute equipment/process validation and reporting.

Applies statistical methods of analysis and process control to current Service operations.

Light work: Exerting up to 40 pounds of force occasionally and/or up to 20 pounds of force frequently and/or a negligible amount of force constantly to move objects

Qualifications & experience:

5 + years of engineering experience in medical device environment.

Must have experience creating and updating quality management system (QMS) documents.

Must have knowledge of applicable domestic and international regulations and quality system standards – FDA QSR, MDD, ISO3485, ISO9001, etc.

Ability to work independently from discovery to implementation.

Ability to work with remote teams as needed.

Excellent communication skills, time management and organization sills with attention to detail.

Previous experience in a regulated environment and understanding of Medical Device manufacturing processes is desirable.

  • **Only those lawfully authorized to work in the designated country associated with the position will be considered.**

  • **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**

Benefits:

For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.

California Pay Equity:

For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.

Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).

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