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20 days old

Junior Quality Engineer

Kelly Services
San Diego, CA 92108
Jr. Quality Engineer


What's next for you? This great job! Kelly is looking for a dynamic Junior Quality Engineer with 2+ years experience working in FDA and ISO 13485 regulated company including experience in biotech / IVD / Medical Device. This is a 6-month contract role, with possibility of extension.


*** MUST BE ABLE TO WORK AS AN EMPLOYEE (ON W-2 BASIS) *** NO C2C, 1099, etc. ***


+ **Location: San Diego, CA**

+ **Pay: $36.00/hour**

+ **Schedule: Weekdays**


This position will be responsible for support of on-going commercial medical device and reagent production activities. Support new product launches, scale up, and continuous improvements through production lines installation and qualification.


**RESPONSIBILITIES:**

Develop/ Write/Oversee IQ/OQ/PQ and PVs for Manufacturing Equipment and Processes

Perform investigations and complete action items for open CAPAs

Complete accurate and timely manufacturing documentation including manufacturing procedures, inspection procedures, materials records, etc.

Develop new test methods and perform test method validation in compliance with FDA and ISO requirements.

Other duties as assigned; as emerging growth company, it may be required from time to time to assist in other areas other than the area of specialty

Support internal and external audits for compliance to ISO 13485 and FDA standards


**KNOWLEDGE AND SKILL:**

Good working knowledge of manufacturing equipment

Good written and verbal communication skills

Ability to resolve issues quickly and recommend preventive solutions

Strong knowledge of statistical analysis

Strong GMP and GDP knowledge

Knowledge of MS office suite

Working knowledge of 13485:2016


**EDUCATION/EXPERIENCE REQUIRED** :

2-5 years experience working in FDA and ISO 13485 regulated company

2-5 years experience in biotech / IVD / Medical Device

Experience with medical device manufacturing processes qualification (IQ/OQ/PQ).

Product manufacturing, inspection, and testing experience

BS required, preferred in Engineering or relatable field


**PHYSICAL DEMANDS:**

Ability to work long hours and execute under pressure with short turnaround times

Ability to speak, write, and use all office equipment including scanner and printer, phone, computer, etc.

Available nights, weekends, and holidays when needed


**Why Kelly?**


As a Kelly employee, youll have access to world-class perks, including:


+ Kelly-sponsored Affordable Care Act health care coverage available to eligible employees

+ *Group insurance options

+ Service bonus plan

+ Holiday pay plan

+ Weekly electronic pay options

+ Online training campus that provides more than 3,000 free courses to help improve and develop skills

+ Exclusive online employee community

+ Employee assistance program available at no cost

+ Corporate discounts

+ Transportation Spending Accounts


*Offered and administered by Leslie & Associates. These plans are not sponsored by Kelly Services.


*Important information: This position is recruited by a remote, national, Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States


**Why Kelly** **** **?**


By partnering with Kelly Technology, youll have direct connections to top companies around the globegiving you the chance to put your tech skills to work on some of todays most intriguing, innovative, and high-visibility projects. In a world where change is the only constant, our unparalleled connections and IT market expertise help you take your skills exactly where you want to go. Were here to help you gain experience, keep learning, and move your career forward.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2021-08-30 Expires: 2021-09-30

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Junior Quality Engineer

Kelly Services
San Diego, CA 92108

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