Senior Quality Manager 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 Site Quality Leader providing oversight, training and mentoring to the organization for quality systems, new product development, sustaining engineering, risk management, receiving inspection, production & process controls, complaint handling, supplier controls and end to end product quality. Job Duties Mentors and leads the OVT Quality staff supporting new product development and sustaining engineering projects. Provides coaching and mentoring in Quality Systems- executing on robust and timely Quality Plans, CAPA's, NC's, Complaint Investigations, AE reporting, trending and signal detection, product issue escalations and a closed-looped Post Market Surveillance process. Site leader and champion for Olympus Quality Systems integration activities. Acts as the site Quality Management Representative - supports facility audits by outside agencies (i.e., FDA, ISO / MDSAP) as a host, front room point of contact and subject matter expert to demonstrate compliance to regulatory requirements and the OVT Quality System. Executes periodic Quality System Management reviews with OVT leadership. Budget responsibility for the local Quality team. Other Quality Assurance responsibilities as assigned by Management. Job Requirements REQUIRED
Qualifications:
Bachelor's degree or equivalent in engineering or life science discipline. Master's degree or other advanced degree strongly preferred. Minimum of 8 years of professional experience or equivalent training or equivalent training/education in Quality or other engineering discipline. Minimum 3 years of people-management experience. Hands-on Medical Device quality systems experience also required. High level of proficiency in Microsoft Word, Outlook, Excel and PowerPoint required. Superior writing, composition, English grammar skills a must. 10-15% domestic and international travel. PREFERRED
Qualifications:
Proven track record in the global execution of New Product Development delivering on robust, customer and patient focused product quality, Concept through Post-Launch for WW markets. Provide quality direction to product development teams to achieve successful product introductions. Strong working knowledge of FDA QSR's, MDSAP, ISO 13485, EUMDR, Quality Systems, Design Controls, Production and Process Controls, Complaint handling, trending, signal detection and post market surveillance. Skilled as a quality systems site management representative, prepping, hosting, leading and managing internal and external audits and CA responses. Strong working knowledge of technical problem-solving skills. Design or Process Black Belt is a plus. Visio skills desirable.
Salary Range:
$100K -- $150K
Minimum Qualification
Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
Qualifications:
Bachelor's degree or equivalent in engineering or life science discipline. Master's degree or other advanced degree strongly preferred. Minimum of 8 years of professional experience or equivalent training or equivalent training/education in Quality or other engineering discipline. Minimum 3 years of people-management experience. Hands-on Medical Device quality systems experience also required. High level of proficiency in Microsoft Word, Outlook, Excel and PowerPoint required. Superior writing, composition, English grammar skills a must. 10-15% domestic and international travel. PREFERRED
Qualifications:
Proven track record in the global execution of New Product Development delivering on robust, customer and patient focused product quality, Concept through Post-Launch for WW markets. Provide quality direction to product development teams to achieve successful product introductions. Strong working knowledge of FDA QSR's, MDSAP, ISO 13485, EUMDR, Quality Systems, Design Controls, Production and Process Controls, Complaint handling, trending, signal detection and post market surveillance. Skilled as a quality systems site management representative, prepping, hosting, leading and managing internal and external audits and CA responses. Strong working knowledge of technical problem-solving skills. Design or Process Black Belt is a plus. Visio skills desirable.
Salary Range:
$100K -- $150K
Minimum Qualification
Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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