Olympus America Inc. Director, Supplier Quality in Southborough, Massachusetts
Bachelor’s Degree in Engineering required; Master’s Degree is preferred.
Minimum of 10 years of experience in Supplier Quality or Quality Engineering in the Medical Device Industry.
Experience leading and managing direct reports is required.
* Strong knowledge of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR's, ISO 13485, & ISO 14971 are required; ISO 13485 Lead Auditor certification is preferred.
- Ability to travel, up to 40%.
Proven ability to lead, champion change, develop and execute strategies to meet goals.
Proficient with DMAIC / Black Belt / Six Sigma type tools to analyze, drive root cause, and solve problems.
Proficient with statistics, sampling strategies, design of experiments, process capability, including statistical software tools such as Minitab.
Proficient with process trouble shooting in the areas of injection and insert molding, extrusion, stamping, wire EDM, and CNC machining.
Understanding of the design, development, and tolerancing of complex systems.
Working knowledge of GD&T is a plus.
Strong written and oral communication skills.
Proficient in most common PC based applications (Word, Excel, PowerPoint, Project & Visio), including Agile PLM.
We realize work isn’t just a job to you.
It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.
As a Supplier Quality Director you will be empowered and inspired to do your best work. A typical day for you will include:
Mentoring and leading the Supplier Quality Organization. Champions the supplier quality management program for legacy products and support of new products under development per OSTA new product development (NPD) process.
Developing the strategy and execute on a proactive, risk-based Supplier Management Governance Process that reviews Supplier Performance and trending for items such as NC’s, CAPA’s, SCAR’s, Audit Results etc.
Leading the evaluation of new or transferred suppliers and/or changes to the Approved Supplier List (ASL) and the Supplier Change Notification (SCNs) process.
Overseeing supplier process management, i.e. risk management, quality assurance agreements, control plans, supplier assessments/audits, submitted validations, process failure modes and effects analysis (pFMEA), CtQ cascades and supplier inspection plan/method evaluations.
Utilizing effective and efficient Quality Engineering techniques such as root cause identification, risk analysis, statistical data analysis, process capability analysis, design of experiments, measurement system analysis, control plans, and development of sampling plans throughout the product lifecycle.
Authoring, collaborating and approving quality system documentation via Agile PLM.
Maintaining responsibility for the direct management of the Supplier Quality Organization.
Carrying out supervisory responsibilities in accordance with the organization's policies and applicable laws, including interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Performing other duties as assigned by management.
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. We’re currently looking for a Director, Supplier Quality to join us in our Southborough, MA office.
Let’s inspire healthier lives, together.
The Director of Supplier Quality provides strategic leadership and focus across supplier quality management activities for OSTA. The incumbent works with external manufacturers and suppliers providing finished products, services, components, and sub-assemblies to ensure compliance with company policies, specifications, procedures, and medical device regulations. He/She will partner with Manufacturing Engineering, Operations, R&D, Supply Chain leaders and other departments to continuously improve products and processes that meet customer and patient requirements.
At Olympus, we put a lot of good back into the world, and what we do really matters. We are committed to making people’s lives healthier, safer and more fulfilling every day by crafting innovative optical and digital solutions in medical technologies, microscopy, industrial solutions, cameras, and audio recorders.
We view our relationship with and commitment to our employees with the same passion. Everything we do at Olympus is a reflection of our vision, and everyone here helps to make it a reality. We’re invested in our employees, great ideas, and how they impact the communities around us. We see the world through multiple lenses and come together to find the right answers; the best solutions.
TRUE TO YOU. TRUE TO SOCIETY. TRUE TO LIFE.
Olympus Surgical Technology America
Olympus embraces diversity and inclusion. As an Equal Opportunity Employer, our policies as well as our values prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification. EOE Minorities/Females/Veterans/Disabled
Olympus Surgical Technology America at http://www.olympus-osta.com/
Southborough GYR ACMI Inc
Director, Supplier Quality
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Olympus is an Equal Opportunity Employer, and our policies prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification.