Apply on Employer Site

Kelly Science, Engineering, Technology & Telecom · 1 day ago

Quality Technician

Earth City, MO

Full-time

Onsite

Entry, Mid Level

1+ years exp

Kelly Science, Engineering, Technology & Telecom is a leading manufacturer of medical equipment. The Quality Technician is responsible for ensuring compliance with quality system requirements, supporting process improvements, and managing equipment calibrations and investigations.

Staffing & Recruiting

No H1B

Responsibilities

Assist with complaint handling processes investigations, calibration process, engineering change order process, and perform corrective and preventive action project activities

Support in the implementation of process controls, NCRs, Product Returns/Rejects/MRB, Calibration system, and CAPA systems designed to meet or exceed internal and external requirements

Must be able to complete in-house gage calibrations along with managing calibration outsourcing activities. Managing equipment files, upkeeping equipment in a calibrated status, and driving improvements in gage use through the inspection/test process

Support and lead efforts of Gage Repeatability and Reproducibility (Gage R&R) and Test Method Validation with manufacturing engineers

Support Quality Inspection Plan updates and equipment evaluation for suitable use on product parameters

Must be able to manage product returns, lead Material Review Board activities

Manages timelines for product and equipment investigations to ensure that reporting is performed on time, technical investigations are addressed in a timely manner, and corrections/corrective actions are performed

Support site quality system activities to ensure compliance with international Regulations and Standards, including but not limited to 21 CFR 820, ISO 13485, EU MDR, and MDSAP requirements

Communicates product compliance and process expectations to the manufacturing floor. Creating work instructions, inspection plans/guides, and monitoring product concerns from manufacturing

Support in the Change Control process with Technical Protocols, Reports and testing data to support changes being made. Including full Validation and Verification plans and completion

Work with process owners to create or update procedures and work instructions to address quality risks

Support internal and external audits by showing compliance of processes owned

Qualification

Quality System complianceCalibration methodsISO 13485 knowledgeQuality engineering certificationEQMS skillsStatistical toolsOrganizationVerbal skillsComputer knowledgeCollaboration skillsWritten skills

Required

Must be able to complete in-house gage calibrations along with managing calibration outsourcing activities

Managing equipment files, upkeeping equipment in a calibrated status, and driving improvements in gage use through the inspection/test process

Support and lead efforts of Gage Repeatability and Reproducibility (Gage R&R) and Test Method Validation with manufacturing engineers

Support Quality Inspection Plan updates and equipment evaluation for suitable use on product parameters

Must be able to manage product returns, lead Material Review Board activities

Support site quality system activities to ensure compliance with international Regulations and Standards, including but not limited to 21 CFR 820, ISO 13485, EU MDR, and MDSAP requirements

Communicates product compliance and process expectations to the manufacturing floor

Creating work instructions, inspection plans/guides, and monitoring product concerns from manufacturing

Support in the Change Control process with Technical Protocols, Reports and testing data to support changes being made

Including full Validation and Verification plans and completion

Work with process owners to create or update procedures and work instructions to address quality risks

Support internal and external audits by showing compliance of processes owned

Organization

Strong written and verbal skills

Collaboration skills

QA process skills

Computer knowledge and skills

Legally authorized to work in the United States

Associates or Bachelors. Degree in an Engineering field is preferred (mechanical preferred)

1 - 3 years' experience in regulated medical device industry highly preferred

Strong familiarity with calibration methods/standards, various gage use, and failed equipment risk analysis

Strong knowledge of global Quality System regulations related Good Manufacturing Practices. (ISO 13485, 9001, 17025)

Preferred

eQMS skills

Knowledge of ISO 13485, MDSAP, 21 CFR 820, MDR 2017/745

Quality engineering (ASQ or similar Certifications)

Professional certification(s) relevant to the position preferred (e.g., CQA, CQM, and/or CQE)

Experience with electronic quality system documentation management and statistical tools such as GageTrak, MiniTab, Solidworks, CAD, PowerBI, Windchill, SAP, QPulse,etc

Excellent written and verbal communication skills

Experience with quality inspection processes and equipment

Knowledge of safety requirements and legal standards