Shift Timing: Monday – Friday, 6am – 2:30pm

Primary responsibilities:

• Assist Quality Engineering with CMM Programing

• Complete FAR (First Article Plans)

• Complete ESI (Engineering Sample Inspection Plans)

• Assist with completing FARs and ESIs

• Complete All Incoming Inspection Activities

• Assist with MRB (Material Review Board) Investigate and Initiate NCR (Non-Conforming Material Report)

• Assists with new part qualification activities, completes documentation necessary for the support of the new part qualification activities

• Assess analytical, calibration, test methods & procedures to identify continuous improvement opportunities

• Maintains the site’s calibration process under the oversight of Quality Engineering, which entails reviewing calibration status, initiating internal calibration

• Assist with the completion of IQ/OQ/PQ qualifications of Quality and software Validations

Secondary responsibilities:

• Participate in compliance external audits, customer audits, and vendor audits. Assists with new part qualification activities, completes documentation necessary for the support of the new part qualification activities

• Conducts both internal quality system audits and process audits

• Assist with development and implementation of quality related procedures and training as directed by Quality Management and Engineering

• Updates quality procedures, instructions and forms as directed by Quality Management and Engineering, data gathering for nonconformance issues, assists Quality Management and Engineering in corrective action activity (root cause analysis and problem solving)

• Must maintain collaborative and effective interaction with Production and Engineering teams in support of the Quality Management System activities

• Assists CAPA processes related to the investigation of root cause, corrective and preventive action plans to include implementation

• Assist Manufacturing, Engineering and Supplier Quality Engineering to isolate product quality problems.

• Assist Quality Engineering in problems related to supplier performance through coordination of internal activities and interface with suppliers, as required

Position Requirements:

The education, experience, skills and training required of the employee for this position are as follows:

• AAS degree in a technical discipline (Electrical / Mechanical or related) with at least 3 years of experience in the manufacturing environment, preferably in medical device

• Familiar with validation and calibration requirements within the medical device manufacturing environment

• Computer competency in MS Word, MS Excel, MS Access, ERP systems, and Calibration databases

• Working knowledge & Internal Quality System Auditing experience for medical devices (ISO 13485), Internal Auditor Experience preferred

• Ability to read and interpret engineering drawings

• Ability and demonstrated knowledge Metrology and Electrical measurement gages

• Demonstrated writing and communication skills

• Experience in interacting with suppliers of optical components, PCBA’s and machined parts preferred.

• CQI (Certified Quality Inspector), CQT (Certified Quality Technician)

Working Conditions:

• May require common protective or safety equipment

• Regularly required to sit or stand and move about the facility. May be exposed to shop elements such as noise, dust and odors

Job Type: Contract

Salary: $17.00 per hour

Experience level:

• 3 years

Schedule:

• Day shift

Work setting:

• In-person
• Manufacturing facility

Ability to commute/relocate:

• Depew, NY 14043: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Manufacturing: 3 years (Preferred)

Shift availability:

• Day Shift (Preferred)

Work Location: One location

Speak with the employer
+91 (848) 200 -2354

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