Supplier Quality Engineer

Essential Functions and Responsibilities

• Execute and comply with global supplier control procedures and processes, including upholding, educating and enforcing said procedure(s) within the European Operations.
• Develop and/or remediate specifications of raw materials and components outsourced from vendors and hold suppliers accountable to agreed upon specifications.
• Management and remediation of supplier quality agreements.
• Approve and qualify new and legacy suppliers as per global procedures.
• Act as main interface for all supplier quality requirements for specific products or components.
• Monitor and report on supplier key performance indicators through scorecards, business reviews, external certifications, periodic business reviews. Maintain and execute standardized processes for material compliance across multiple sites to ensure compliance.
• Responsible for anything in Material Review Board that is SCAR related, and is an overall Stakeholder in all European Operations sites MRB.
• Identify and lead assigned continuous improvement projects for either suppliers or internal cross-functional teams.
• Review and collaborate with Design Engineering and Operations in material / component specification.
• Identify opportunities for product, specification or process improvements within the supply chain, the operations and engineering to enhance quality and efficiency.
• Manage applicable supplier corrective actions to assure effectiveness and avoid repeat issues.
• Facilitate and host business reviews with applicable suppliers on regular frequencies dependent on risk.
• Follow Employee guidelines and Quality System Regulations as defined by Nissha Medical Technologies, policies and Standard Operating Procedures to ensure that customer requirements and industry standards and or regulations are met.
• Demonstrate knowledge and act in accordance with NMT's Employee Guidelines and applicable quality standards as outlined in NMT's Quality Manual.
• Investigate and analyze non conformance's and compliance in relation to supplier issues.
• Review documentation and standards pertinent to supplier controls.
• Help determine and implement component/ raw material inspection specifications/ criteria required for quality assurance activities.
• Participate in internal and external audits.

Experience, Knowledge, Skills and Attributes

• Minimum of 3 years of related QE (or similar) experience (Medical Device preferred)
• Familiarity with Quality Systems and regulatory agencies. Preferably ISO 13485, EU MDR 2017/745, and FDA 21 CFR 820
• Bachelor's Degree (BA or BS) from a four-year College or University. Engineering or a related field, preferred.
• Highly organized, detail oriented and works effectively as both a team member and independent contributor
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals
• Ability to write routine reports and correspondence
• Ability to apply logical and systematic understanding to carry out instructions furnished in written, oral or diagram forms
• Works well in a global/matrix organization, as part of an international business, with time-zones and cultures

Nissha Medical Technologies is committed to fair, competitive, and market-informed pay for our employees. The pay range for this position is $70,000-80,000 Annual (USD). The successful candidate's particular combination of knowledge, skills, and experience will inform their specific compensation.

Why choose Nissha to build your career?

At Nissha, you can be assured that you will be part of a dynamic, diverse team that is committed to bringing the best versions of ourselves each and every day. We recently received the "General Excellence" manufacturing award from Buffalo Business First, which highlights our dedication to quality, innovation, and sustainability. This recognition celebrates the hard work of our team in producing high-quality medical devices that meet industry standards and enhance patient care. If you are looking for meaningful work that motivates and inspires, you've come to the right place!

What we offer that you'll love...

• Company Culture: At Nissha, we pride ourselves on cultivating an atmosphere of teamwork where all associates feel heard and valued. We may not all think the same, and we wouldn't have it any other way.
• Diversity & Inclusion: We are committed to equity, racial justice, and equal opportunity for all.
• Training and Development opportunities: Because we foster a culture of continuing education. Let's learn and grow together!
• Team Building, Connection, and Relationships: We support each other, celebrate our achievements and milestones together, and have FUN.
• Retirement: We know you want to retire comfortably and we're here to help! Nissha offers a 401(k) Retirement Plan with an attractive employer contribution.
• Time Away from Work: Whether it is vacation or sick leave, we all need time to recharge. Paid time off is an essential associate benefit and a pillar of self-care.
• Engagement Activities: Recognition isn't just a once-a-year occurrence at Nissha. We celebrate our team members year-round with summer picnics, holiday parties, and employee spotlight events, just to name a few.
• Commitment to Wellness: We offer various opportunities to learn about your health, be healthier, and get rewarded for your healthy lifestyle by offering reduced medical premiums.

And so much MORE!