Metrology Specialist
Metrology Specialist
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Job Description
Our client a leader in the manufacturing of devices and components for major medical device companies is looking for a Metrology Specialist to join their organization. They offer competitive compensation and excellent benefits including 401k health/dental vision and paid time off. They maintain a modern clean and safe facility with stateoftheart equipment and dedication to continuous improvement. The company is registered with the FDA Medical Device Manufacturer and is certified to ISO 13485.
SUMMARY OF POSITION:
This position will be responsible for the activities associated with developing advanced metrology methods in a medical device manufacturing environment. This includes but is not limited to assessing process risk and implementing appropriate control mechanisms corrective / preventative action and creating and refining test methods
ESSENTIAL FUNCTIONS:
- Must be knowledgeable of and adhere to the company Quality Management System.
- Operates and programs advanced measurement equipment including Vision Systems CMMs PLCs Optical Sensors Contracers and Laser Measurement Systems.
- Acts as the Subject Matter Expert in GD&T.
- Uses expertise in bench layouts to resolve complex measurement challenges.
- Collaborates and defines Test Method.
- Expertise of precision measuring instruments and their application including but not limited to electronic height gages calipers micrometers depth gages indicators and plug and thread Go/No Go gages.
- Execution and evaluation of Test Method Validations.
- Support the creation of production visual standards and standardized acceptance criteria for the companys manufacturing processes.
- Design Model and Build inspection work holding fixtures.
- Provides hands on direction for executing Incoming InProcess and Final Product Inspection plans.
- Champion First Article Inspections.
- Support Gage calibration review management execution and evaluation.
- Establish standards for Gage Calibration.
- Competency with materials testing chemistry and mechanical testing.
- Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.
- Support the tracking and reporting of inspection data including but not limited to rejection rates defect modes and process trends across customers/product families.
- Reviews ECOs for the release of Quality Engineering documentation.
- Creates inspection instructions.
- Other duties and responsibilities as assigned.
QUALIFICATIONS:
Education/Experience
- Technical training in GD&T and measurement programing system.
- Minimum of 04 years experience in a regulated manufacturing environment.
- Minimum of 3 years of manufacturing quality experience including advanced metrology experience including CMM and/or Vision System programming.
Qualifications
- Ability to travel up to 5%.
- Demonstrated selfstarter with ability to work in a fastpaced environment.
- Competency with Microsoft Office (i.e. Outlook Word Excel and PowerPoint)
- Strong verbal and written English language communication skills.
- Basic understanding of statistical techniques and sampling strategies
Preferred skills
- ASQCQT CQE or CRE preferred.
- Certifications in DMIS programming preferred.
- Class I II and/or III Medical Device manufacturing experience.
- Regulated manufacturing industry experience (e.g. Aerospace Defense Pharmaceutical etc.).
- Knowledge and experience with external standards: ISO 900/9001 ISO 13485 and 21CFR 820 EU MDR especially pertaining to product development design controls good manufacturing practices supplier qualification auditing quality control (GD&T Nonconforming Materials MRB) Corrective and Preventive Actions and customer complaints).
Physical Demands
While performing the duties of this job the employee is frequently required to sit talk and/or hear and/or use hands to finger handle or touch objects tools or controls. The employee is occasionally required to stand and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.
Employment Type
Full Time
