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.
- 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.
- KEY SKILL / KNOWLEDGE REQUIREMENTS: 3.1. SKILL SETS:
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.
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.
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.
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*
*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