Senior Quality Design Engineer

Kelly Engineering has an opportunity for a Senior Quality Design Engineer to work in Rochester, NY for a renown medical device client. This is a short-term contract with competitive hourly pay.

The role includes working with multidisciplinary teams to ensure medical device development and remediation activities are planned and executed in compliance with design control requirements of company quality management system, ISO, FDA, and other regulatory agencies. Additionally, this role has oversight of the development and maintenance of contact lens device history & risk management files for all assigned products.

The role will support marketed product changes and updates (MOB) and represent design quality on new product development and/or device maintenance of business (MOB) teams.

Responsibilities

• Ensure project plans comply with FDA, EU MDR, and ISO design control requirements.
• Ensure projects adequately meet design, development, technology transfer, validation, and post launch requirements in accordance with the corporate product development process (PDP).
• Manage the documentation of product design control activities (i.e. DHFI, etc.)
• Manage product risk management requirements per ISO 14971.
• Review and approve equipment qualifications, product/process specifications, analytical method qualifications, development engineering protocols, validation strategies/protocols/reports, clinical trial material protocols & batch records, QCR’s etc.
• Issue QA Product Release authorizations for new products
• Complete and provide risk management and/or complaint data updates to annual Product Quality Reviews (PQR), revisions to Design Risk Analysis, and input to Clinical Evaluation Reports.
• Support post launch design changes as required.
• Support internal and external audits as a design quality subject matter expert. This includes providing front room and/or back room support as required.

Qualifications:

• Minimum of BS in quality sciences or scientific/engineering discipline.
• Preference with Chemistry background.
• Minimum 4 years in medical device or pharmaceutical industry in Quality, R&D, Engineering or Laboratory environment
• Familiarity with relevant regulations and standards (i.e., FDA 21 CFR, EU MDD/MDR, ISO-13485, ISO-14971).
  
  

Any additional expertise in the below fields are highly preferred:

• Medical device product development.
• Risk management experience.
• Previous Compliant management, complaint review and corrective action.
• Quality experience in medical device or pharma industry.
• Knowledge of structured problem solving, six sigma, and lean tools.
  
  

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.