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Job description:

We are a leading manufacturer of Ventilators, Carbon Dioxide Absorbents, Suction Regulators/Aspirators and Medical Gas Systems, for hospital and patient care in home or emergency situations.

The Quality Technician is responsible for ensuring compliance with the US and International Quality System requirements. Areas of focus are process and equipment management, process improvement, and failure investigation.

+ 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.

Essential Skills:

+ 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

Desirable Skills:

+ eQMS skills

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

+ Quality engineering (ASQ or similar Certifications)

Essential Experience:

+ 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 Manufacuting Practices. (ISO 13485, 9001, 17025)

+ Legally authorized to work in the United States.

Desirable Experience:

+ 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

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.