- Professional
- Optionales Büro in Somerset
About Us:
SMC, Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people.
Job Summary: Responsible for managing the Metrology Department, ensuring all measurement processes, softwares, equipment, and calibration activities meet organizational requirements and regulatory standards to establish and maintain a Global Metrology Center of Excellence that supports all SMC. Leading a team of metrologist and calibration technician to collaborate with quality, engineering, and production teams to support accurate and reliable measurements and equipment for product development and manufacturing process.
Essential Job Duties and Responsibilities:
- Supervise with direct reporting responsibilities, mentor, train, and assigning priorities to ensure consistent performance and professional development to meet SMC and Customer expectations.
- Create and manage quotes, PO, and Sales orders for CT (Computer Topography) requests for Global sites.
- Manage the selection, procurement, and maintenance of metrology equipment, including CT (Computer Topography), Coordinate Measuring Machines (CMMs), Vision Measurement Machines (VMMs), gauges, and other precision instruments.
- Manage metrology department’s budget, including equipment and software purchases, maintenance costs, and staffing needs; including administration of Global software applications (e.g., Minitab, Volume Graphics).
- Oversee the calibration, maintenance, and certification of measurement equipment, ensuring traceability to national or international standards (e.g., NIST).
- Develop training programs for staff on metrology practices, equipment usage, and compliance requirements.
- Provides technical support and guidance to direct and indirect reports for validation planning, execution, results, troubleshooting, and throughput.
- Develop, enhance, and implements systems, procedures, and strategies to establish or improve overall quality standards, standard repairs, process controls, and inspection methods to be compliant to ISO 13485, cGMP, and FDA systems and procedures.
- Analyze measurement data to identify trends, improve processes, and reduce measurement uncertainties.
- Collaborates with customers and other stakeholders to identify and resolve problems with delivered products.
- Solicits feedback from internal and external customers; Develops and implements improvements.
- Performs other duties as assigned.
Essential Qualifications:
- B.S. in Engineering with an emphasis on Metrology OR six years of related Quality experience.
- Minimum 5-7 years of metrology, calibration, or quality experience in pharmaceutical, medical device, or combination product manufacturing, with at least 2 years supervisory experience.
- Working knowledge of cGMP, ISO 13485, FDA requirements, and other applicable regulation encompassed with the ability and skill to represent SMC in regulatory audits.
- Strong supervisory and leadership skills.
- Solid understanding and application of GD&T, CT, CAD, Blueprint interpretation, and metrology equipment.
- Familiarity with statistical software and analysis tools (Minitab)
- Strong customer relations, customer audits and statistical skills.
- Demonstrated effective verbal and written communication skills.
- Excellent organizational skills and attention to detail.
- Excellent time management skills with a proven ability to meet deadlines.
- Strong analytical and problem-solving skills.
- Proficient PC skills in a Windows environment.
Desirable Qualifications:
- Preferred certifications include ASQ Certified Quality Engineer (CQE), Certified Calibration Technician (CCT), or equivalent.
- Experience in the injection molding industry preferred.
ADA Requirements:
- Typically sits, grasps items and performs keyboarding for frequent operation of a computer
- Stand, walk, bend, reach or otherwise move about occasionally
- Lift, move or otherwise transfer items up to 50 lbs. occasionally
- Exposure to typical machine shop physical hazards which may require respiratory protection
At SMC Ltd. we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process.
SMC Ltd. is an equal opportunity employer. M/F/D/V; this organization uses E-Verify.
Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.
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