San Diego, California

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, you’ll 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, you’ll have direct connections to top companies around the globe—giving you the chance to put your tech skills to work on some of today’s 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. We’re here to help you gain experience, keep learning, and move your career forward.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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.

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San Diego, California

Why Kelly - Since 2011 we have placed over 16,000 Veterans

Need More?

Kelly applies targeted recruiting initiatives to the Veterans population (in all stages of transition) by aligning customer defined requirements with military skills and experience.  The transition from military to civilian life can be stressful and complex for veterans, and our staff is trained to assist in this transition.  Unlike our competition, Kelly places these resources without geographic or industry constraints, offering our customers and our employees greater flexibility.  Kelly has a wide variety of local opportunities, for Veterans and their spouses, within our workforce solutions as well as national recruiting programs on behalf of our customers.  Kelly’s leading placement opportunities for Veterans are within Information Technology, Engineering, Science, Light Industrial and Call Center.

Our specially trained Veteran recruiters are armed with a number of tools to help Veterans obtain roles that match their potential including skill translation tools, leading Veteran- centric job boards and Veteran/spouse social media networks, among others.

Through Kelly’s vast branch network, we are closely located to the majority of major military installations across the United States.  Kelly recruiters participate in onsite and virtual military career fairs as well as advertise through local and national Veteran job boards.  In recent years, over 150 Kelly branches have worked directly with their local military installations to recruit spouses and transitioning personnel.  These teams not only engages with transitioning talent from local bases, but also have a strong focus on Veterans in areas where the military has identified high Veteran unemployment. This approach ensures that military talent is engaged and shared across the centralized military recruiting team and documented in a centralized database, so that other Kelly locations can benefit from hiring or relocating this valuable pool of talent.

Our focus on military recruiting is a win on multiple levels. Kelly gains top talent with the skills needed to excel; our clients receive the benefit of that talent to help them compete in an ever challenging business landscape; and Veterans receive gainful employment in line with their skills and abilities to ease the transition to the next phase of their lives.

A People Company, Staffing the World

Kelly founded the temporary staffing industry in 1946, and has maintained a leadership position through the years based on a valuable premise: we invest in people. Today that focus benefits our customers wherever they operate around the globe - in a growing number of specialized fields. And we’ll continue to meet the evolving challenges of workforce flexibility with staffing solutions tailored to your precise business needs, both locally and worldwide.

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