Sr Mgr, Quality Assurance
? Strong experience with MS Office Products (Word, Excel, Visio, Project, PowerPoint, Outlook, etc.)
? Strong knowledge of inspection/sampling techniques and familiarity with ANSI/ASQ Z1.4
? A solid understanding of the FDA QSR and/or ISO 9000/ISO 13485 Quality System Requirements, and the ability to apply the knowledge to comply with goals and objectives.
? Excellent oral and written communication skills with the ability to communicate with audiences of varying technical skills
? A strong ability to prepare written technical plans and reports in support of engineering changes, product or process validations, and component qualifications.
? Strong familiarity with mechanical and physical inspection techniques (calipers, micrometers, depth gauges, blueprint reading, optical comparator, etc.)
? Strong project planning skills and a strong focus on meeting customer needs.
? Demonstrated strong attention to detail and "do it right the first time” attitude
Additional Desirable Qualifications Skills and Knowledge:
? ASQ Certified Quality Engineer, ASQ Certified Quality Auditor, or equivalent.
? Familiarity with ISO14971 and associated Risk Management Processes
? Familiarity with automated and semi-automated inspection equipment such as Coordinate Measurement Systems
? Strong familiarity with Windows XP and Windows 7
? Ability to work with and motivate people.
? Proven leadership skills in a fast pace environment.
Education and/or Experience:
? Bachelors Degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, etc)
? 5-7 years of experience in the manufacture of Electro-Mechanical devices
? 3-5 years experience in FDA regulated Medical Device Manufacturing
? Majority of time is spent working in an office
? Ability to travel overnight to supplier sites (?20%)
? Standard Operating Procedure training will be provided upon hire