Sr Product Quality Engineer

Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting 12+ month, long term contract opportunity as a Sr. Product Quality Engineer for a top fortune 500 company in Round Lake, IL.

  • Duration: 12 Months+
  • Local candidates are preferred
  • Pay Range: $40-$52/Hour DOE

Description:

The Product Quality Engineer applies a solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise toward the development of new or enhanced products. The Quality Engineer will lead from a technical quality perspective to support product development, design change control and verification/validation activities. This position requires a functional understanding of FDA, ISO and Quality systems.

Essential Duties and Responsibilities:
• Ensure compliance with global quality systems and Regulatory requirements related to product and process Design Control, risk analysis, investigations, and CAPAs
• Support the sustainability and life cycle management of an existing product
• Perform design change control activities including impact assessments, reviews, and approvals
• Provide Quality Assurance support and guidance for verification and validation of product requirements
• Support risk management activities as they relate to post market surveillance
• Use statistical trending tools to monitor product complaint trends
• Take lead role in CAPA activities such as investigation, implementation, or verification of effectiveness
• Develop and participate in the development of solutions to problems specific to assigned project
• Interact with off-shore suppliers to complete project related activities
• Independently plan, schedule and lead cross-functional team in detailed phases of the Quality work in a project
• Maintain a high level of expertise in current regulatory requirements
• Perform other duties as assigned

Top Skills for this role:

1. experience with change control

2. understanding of DHF management

3. medical device experience

4. experience with electro-mechanical products

5. Engineering degree


Qualifications for this Role:
• Must have experience or advanced training and demonstrate proficiency in statistical methods
• Completely proficient in relevant products or process development processes
• Strong interpersonal/communication/influencing/negotiation skills
• Good project management skills
• Extensive cross-functional team experience, including technical and non-technical work
• Ability to diagnose problems and recommend solutions in assigned project
• Duties may require work outside regular business hours

Education and Experience
• Bachelors of Science degree in Engineering (discipline: electrical / mechanical / biomedical)
• 4-8 years’ recent relevant experience in the medical device industry.
• Previous experience working with Electromechanical IV pumps or syringe pumps, preferred.
• Demonstrated success in delivering results on technical/product/Quality challenges
• Experience in design control and strong knowledge of DHF and configuration management
• Working knowledge of medical device international standards
• Working knowledge of problem solving and statistical methods as applied to process and product quality preferred
• Product development experience pertaining to electromechanical devices preferred
• Software: Excel (pivot tables, v-lookups)*, Minitab*, Word, PowerPoint, Trackwise 8 (change control / compliant), & TCU

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. Please apply online or contact luisa.ruthner@kellyservices.com for immediate consideration

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.

About Kelly 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 2017 was $5.4 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.

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