Senior Quality Engineer at Olympus Corporation of the Americas in Missouri City, MO
Are you looking for a company that cares about people's lives and health, including yours? At Olympus, we help make people's lives healthier, safer and more fulfilling, every day. Let's inspire healthier lives, together. Job Description The Sr. Quality Engineer supports the development and manufacture of Olympus products during all phases of design, development, production, and distribution. Job Duties 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 including supporting internal and external audits, creating/revising SOPs and work instructions, and coordinating training assignments. Serves as a mentor for the Quality team, when necessary, to assist in developing Quality Engineering skills. Support design and development projects including but not limited to risk analysis activities (design and process FMEAs), verification and validation activities, acceptance criteria and inspection methods, product labeling and specifications, and review of Design History File. Support and maintain device production and distribution activities. Support and participate in Corrective and Preventive Action activities. Job Requirements REQUIRED
Qualifications:
Bachelor's degree, or equivalent, in an engineering or life science discipline is preferred. Minimum of 3 years working in an FDA regulated environment optimal (Minimum of 1 year required). Minimum of 5 years progressively responsible experience operating as a Quality Engineer in a highly regulated manufacturing environment or equivalent experience required. Sophisticated written and verbal communication skills, including previous experience in procedure, protocol and report writing required. Some travel will be required (less than 5%) Some extended workdays may be required. PREFERRED QUALIFICATIONS Knowledge of ISO 13485, 21 CFR Part 820, 93/42/EEC Medical Devices Directive, EU Regulation 2017/745, SOR 98/282, Canadian Medical Device Regulations, 21 CFR Part 11, ISO 14971, ISO 11135, ISO 10993-1, ISO 11607 and other medical device industry US and international standards. Experience with risk analysis and reliability engineering techniques. 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. ASQ CQA and/or CQE a plus.
Salary Range:
$80K -- $100K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
Qualifications:
Bachelor's degree, or equivalent, in an engineering or life science discipline is preferred. Minimum of 3 years working in an FDA regulated environment optimal (Minimum of 1 year required). Minimum of 5 years progressively responsible experience operating as a Quality Engineer in a highly regulated manufacturing environment or equivalent experience required. Sophisticated written and verbal communication skills, including previous experience in procedure, protocol and report writing required. Some travel will be required (less than 5%) Some extended workdays may be required. PREFERRED QUALIFICATIONS Knowledge of ISO 13485, 21 CFR Part 820, 93/42/EEC Medical Devices Directive, EU Regulation 2017/745, SOR 98/282, Canadian Medical Device Regulations, 21 CFR Part 11, ISO 14971, ISO 11135, ISO 10993-1, ISO 11607 and other medical device industry US and international standards. Experience with risk analysis and reliability engineering techniques. 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. ASQ CQA and/or CQE a plus.
Salary Range:
$80K -- $100K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
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