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®

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. 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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