Kelly Services Quality Engineering Specialist in Blue Ash, Ohio

Quality Engineering Specialist

Kelly Services is currently seeking a Quality Engineering Specialist for one of our top clients in Blue Ash, OH or Somerville, NJ.

The Quality Engineering Specialist is responsible for:

  • Coordinating all Repack Relabel RPRL requests for review by the appropriate Quality Engineering subject matter expert.

  • Ensure timely Quality Engineering review of RPRL requests.

  • Coordinate additional information needed to disposition RPRL requests with local operating companies.

  • Review current RPRL processes at affiliate s sites, evaluate the risks, compare them to existing risk documentation, and help provide recommendations to approve, reject, or partner to create a new solution.

  1. EDUCATION / DEGREE REQUIRED:
  • BS or BA in business, quality or engineering

  • CQA Quality Auditor Certification and/or CQE, Quality Engineer Certification desired

  • Strong working knowledge of Quality System regulations and industry trends.

  • PE certification desirable.

  • Advanced degree or MBA desirable.

  1. KEY SKILL / KNOWLEDGE REQUIREMENTS: 3.1. SKILL SETS:
  • Ethical

  • Decision making - overcome major obstacles with limited facts or without precedence or policy.

  • Project management able to handle multiple and competing activities.

  • Knowledge of and ability to apply the following in course of daily activities:

  • Configuration Management II principles and Product Lifecycle Management PLM.

  • DMACII principles and continuous improvement methodologies.

  • Training principles.

  • Communication able to deliver complex quality issues and concepts in a clear and concise manner, orally and in writing - with all levels of worldwide management.

  • Effect and influence - systems-level change, gain cooperation and action from others.

  • Conflict management able to handle and resolve conflict situations and influence key business stakeholders to deliver mutually beneficial outcomes.

  • Results and performance driven assumes personal ownership for business results and solutions; makes the customer central to all thinking

  • Functional knowledge of ISO International Organization for Standardization , other applicable International regulatory regulations and Good Manufacturing Practices GMP per Code of Federal Regulations, Part 820.

3.2. COMPUTER SKILLS:

  • Personal computer skills, Windows: word processing, project planning, presentation, e-mail and spreadsheet software.

3.3. EXPERIENCE:

  • 5 years relevant Quality Engineering experience.

  • 3 years of experience in Quality Systems in a FDA Food Drug Administration regulated environment.

  • Managing projects which lead to positive, tangible business results.

  • Auditing for compliance to ISO standards for QMS, MDD, FDA QSR and CMDR.

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

Why Kelly?

  • As a Kelly Services employee, you will have access to numerous perks, including:

  • Exposure to a variety of career opportunities as a result of our expansive network of client companies

  • Career guides, information and tools to help you successfully position yourself throughout every stage of your career

  • Access to more than 3,000 online training courses through our Kelly Learning Center

  • Weekly pay and service bonus plans

  • Group-rate insurance options available immediately upon hire*

Apply Today!

*Available for purchase and administered by a designated third-party vendor

Why Kelly ® ?

Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short term project engagements, or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.

AboutKelly Services ®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm