Principal Quality Engineer at Olympus Corporation of the Americas in Center Valley, PA
Are you looking for a company that cares about people's lives and health, including yours? Olympus is passionate about creating customer-driven solutions for the medical, life sciences, and industrial equipment industries. For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. Job Description The Principal Quality Engineer supports the development and manufacture of Olympus Veran Technologies (OVT) products during all phases of design, development, production, and distribution. Job Duties The Principal Quality Engineer is responsible for:
Acting as the Quality Representative on Product Development project teams. Working cross-functionally to generate and maintain product Risk Management file(s). Reviewing QMS and product Design Changes. Defining Inspection and test methods and systems. Complaint handling and product investigations of device returns. Support continuous improvement opportunities. Preparing and maintaining Quality Metrics. Maintenance of Quality Management System by ensuring compliance to U.S. and international regulatory requirements for medical devices. Serves as a mentor for the Quality Engineering team to assist in developing Quality. Support design and development projects. Support and maintain device production and distribution activities, addressing quality issues and resolution using the current quality techniques and principles. Participates in the CAPA process as required as an assignee or project team lead. Job Requirements REQUIRED QUALIFICATIONS Bachelor's degree or equivalent in an engineering or life science discipline. Minimum of 12 years of progressively responsible experience operating as a Quality Engineer in a highly regulated manufacturing environment or equivalent experience required. Severn or more years working in an FDA regulated environment optimal (Minimum of 5 years required). Some travel will be required (less than 5%); Some extended workdays may be required. PREFERRED QUALIFICATIONS Leadership
Experience:
proven ability to lead and mange cross-functional teams, effectively communicate with all levels of management and drive effective change. Experience with risk analysis and reliability engineering techniques. Identifying requirements, setting realistic scheduling, and meeting deadlines. Ability to identify issues, determine root cause, and implement solutions. Ensure compliance to standards, regulations, and Company procedures. Identify and facilitate process and SOP improvements within the Quality System, embracing a culture of continuous improvement. Advanced Microsoft software skills including sophisticated Word, Excel and PowerPoint skills preferred. Access, Visio, database, and statistical analysis software experience optimal. A natural at fostering collaborative relationships across all lines of the Company. This position is eligible for a sign-on bonus.
Salary Range:
$100K -- $150K
Minimum Qualification
Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
Acting as the Quality Representative on Product Development project teams. Working cross-functionally to generate and maintain product Risk Management file(s). Reviewing QMS and product Design Changes. Defining Inspection and test methods and systems. Complaint handling and product investigations of device returns. Support continuous improvement opportunities. Preparing and maintaining Quality Metrics. Maintenance of Quality Management System by ensuring compliance to U.S. and international regulatory requirements for medical devices. Serves as a mentor for the Quality Engineering team to assist in developing Quality. Support design and development projects. Support and maintain device production and distribution activities, addressing quality issues and resolution using the current quality techniques and principles. Participates in the CAPA process as required as an assignee or project team lead. Job Requirements REQUIRED QUALIFICATIONS Bachelor's degree or equivalent in an engineering or life science discipline. Minimum of 12 years of progressively responsible experience operating as a Quality Engineer in a highly regulated manufacturing environment or equivalent experience required. Severn or more years working in an FDA regulated environment optimal (Minimum of 5 years required). Some travel will be required (less than 5%); Some extended workdays may be required. PREFERRED QUALIFICATIONS Leadership
Experience:
proven ability to lead and mange cross-functional teams, effectively communicate with all levels of management and drive effective change. Experience with risk analysis and reliability engineering techniques. Identifying requirements, setting realistic scheduling, and meeting deadlines. Ability to identify issues, determine root cause, and implement solutions. Ensure compliance to standards, regulations, and Company procedures. Identify and facilitate process and SOP improvements within the Quality System, embracing a culture of continuous improvement. Advanced Microsoft software skills including sophisticated Word, Excel and PowerPoint skills preferred. Access, Visio, database, and statistical analysis software experience optimal. A natural at fostering collaborative relationships across all lines of the Company. This position is eligible for a sign-on bonus.
Salary Range:
$100K -- $150K
Minimum Qualification
Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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