Global Metrology Manager

Summary

Title: Global Metrology Manager

ID: 2500

Department: Quality

Location: Buffalo, NY

Description

Nissha Medical Technologies is excited to be hiring for a Global Metrology Manager as an important add to our Quality Team! This position will develop, maintain, and support the measurement capabilities and efficiencies across all Nissha facilities. You will track and manage metrology capacity and planning, continuously improve Quality performance in the Inspection areas of sustaining production, and in support of new product development. Positively impact metrics related to the strength of Quality System. Mentor less experienced Engineers within in best practices for the use of measurement equipment and optimal inspection methods. May be asked to train R&D Engineers, Quality Techs, and Quality Inspector I and/or IIs. As a member of the company’s Quality Leadership Team, the successful candidate will lead the development, articulation, implementation, and continuous improvement of Global Metrology Projects.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Develop, maintain, and support the measurement capabilities and efficiencies at across Nissha, as applicable.

• Project management and capacity tracking for both new product introduction and sustaining production.

• Responsible for ensuring that the measurement capabilities at the site are adequate given the complexity of the dimensions measured. Justify and order new equipment, as needed.

• Ensure that IQ, OQs, PQs, and TMVs are completed for new measurement equipment in Quality and Production.

• Execute standardized software validation activities on all system updates.

• Utilize Minitab for Gage R&R.

• Program inspection equipment to include CMM, Optical Hybrid CMM, Optiv, Jenoptik, Keyence, Optical Comparators, and others, as applicable.

• Understand how to demonstrate improvements in inspection capability and capacity at a site level.

• Use quality tools, equipment, gages, and other measurement tools and devices to make “pass/ fail” decisions based on the guidelines in the organizational quality management system.

• Use Statistical Process Control (SPC) for analysis and quality decision making.

• Exercise Lean Manufacturing principles during program development for efficiency.

• Able to assist R&D with print development and create Inspection Procedures

• Prefer experience in defining dimensions, considering feature criticalities.

• Knowledge of sampling plans and application.

• Good negotiation skills with Engineers, Inspection management, Design Quality Assurance, Supplier Quality, and Purchasing.

• Ability to manage all or elements of the Calibration system planning and oversight, including creating requisitions or Purchase Orders for new equipment

• Be able to perform the general responsibilities of a Quality Engineer related to Metrology:

• Initiate NCR’s when necessary and communicates failures or other inspection issues to the appropriate resources.

• Follow GMP, FDA, ISO, and internal operational procedures.

• Serve as a quality resource on CAPA projects and investigations.

• Initiates and collaborates on change orders related to metrology and inspection.

• Follow Employee guidelines and Quality System Regulations as defined by Nissha Medical Technologies practices, 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.

• Identify and drive continuous improvement of quality procedures and compliance projects at all manufacturing sites ensuring harmonization, simplification and globalization. All processes and products must meet high internal standards and regulatory requirements and ultimately deliver high-quality, cost-effective products to the customer.

• Ensure compliance of Site SOPs with Global Policies and SOPs.

• Coach and develop as appropriate, indirect reports through ongoing, example-based performance feedback, and the provision of training and development opportunities.

• Lead initiatives to harmonize systems across manufacturing sites where appropriate.

• Foster an environment of collaboration, trust, quality, innovation and continuous improvement within the Company and between functional departments.

• Lead change in the organization to continuously adapt to a dynamic business environment; apply learning to enhance organizational performance.

• Proactively identify issues, concerns or any potential or significant risks to the business and ensure that appropriate preventative actions are in place at all sites.

MINIMUM QUALIFICATIONS

• Bachelor’s Degree from a four-year College or University in engineering or equivalent in a related discipline.

• At least two years of programming experience of CMMs, Optical Hybrid CMM, & Tesa equipment.

• Prefer experience in a regulated environment (e.g. Medical Device, Aerospace, or Automotive experience)

• Preferred experience in Calypso and PC-DMIS programming languages

• Blueprint reading experience and interpretation (prefer GD&T trained)

• Proficient in Minitab

• General knowledge of Excel, Word, and Outlook.

• Prefer experience with Oracle systems.

• Effective communication skills.

• Demonstrated proficiency in leading cross functional groups to conclusions.

Starting salary range of $120-160k annually + comprehensive benefits package

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!