Product Quality Manager at Olympus Corporation of the Americas in Brooklyn, MI
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 Quality Leader providing strategy execution, oversight, training and mentoring to the organization for new product development, sustaining engineering, risk management and end to end product quality. Directly responsible for the Product Quality Organization in Brooklyn Park, MN - including ProductQuality Engineering, and the Human Factors Engineering support. Job Duties Executes vision and strategy for the Brooklyn Park owned product development process outputs, portfolio and pathologies. Mentors and leads the Brooklyn Park Product Quality Engineering staff supporting new product development and sustaining engineering projects. Mentors and leads the Human Factors/ Usability Team supporting new product development and sustaining engineering projects at the site. Champion and subject matter expert for customer and patient focused end to end Risk Management. Supports all aspects of the product lifecycle for products in scope, including sustaining activities, design change management, complaint investigations and ongoing risk management activities/post market surveillance. Supports facility audits by outside agencies (i.e., FDA, ISO / MDSAP) and acts as a subject matter expert to demonstrate compliance to regulatory requirements and the Olympus Quality System. Stakeholder and collaborator with senior management relating to project, process, business, and quality decisions. Other Quality responsibilities and special projects 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 of 3 years working in medical device new product development and people leadership. Other Considerations (travel/hours availability, etc.):
up to 15% domestic 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. Strong technical skills related to product quality including VOC translation to Design Specs, Human Factors, CTQ Cascades, Design Characterization, Verification / Validation, Test Method Validation, Process Validation, Inspection Techniques and Statistics. Ability to drive value and product differentiation through the Product Quality Team. Strong working knowledge of FDA QSR's, MDSAP, ISO 13485, EUMDR, Design Controls, Human Factors, Risk Management practices. Strong working knowledge of technical problem-solving skills. Design or Process Black Belt is a plus. Strong collaboration and influencing skills and the ability to work across functions. Must be a change agent, highly and effectively organized, be a flexible self-starter, team-oriented and excellent at prioritization and multitasking.
Salary Range:
$80K -- $100K
Minimum Qualification
Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
up to 15% domestic 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. Strong technical skills related to product quality including VOC translation to Design Specs, Human Factors, CTQ Cascades, Design Characterization, Verification / Validation, Test Method Validation, Process Validation, Inspection Techniques and Statistics. Ability to drive value and product differentiation through the Product Quality Team. Strong working knowledge of FDA QSR's, MDSAP, ISO 13485, EUMDR, Design Controls, Human Factors, Risk Management practices. Strong working knowledge of technical problem-solving skills. Design or Process Black Belt is a plus. Strong collaboration and influencing skills and the ability to work across functions. Must be a change agent, highly and effectively organized, be a flexible self-starter, team-oriented and excellent at prioritization and multitasking.
Salary Range:
$80K -- $100K
Minimum Qualification
Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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