Engineer II, QA

When you join Thermo Fisher Scientific, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science and with the largest investment in R&D in the industry, you will be empowered to realize your full potential as part of a fast-growing, global organization that values your passion and outstanding contributions. Our commitment to you and our 80,000 colleagues is to provide the resources and opportunities you need to make a difference in our world while building a fulfilling career with us.

How will you make an impact?

We are looking for a driven, inventive Quality Assurance Engineer with demonstrated experience driving and sustaining improvement to products while ensuring that those products manufactured meet internal, customer, and regulatory requirements. This position is responsible for executing the Customer Complaint Management process as per the Quality System to ensure that the product or process quality requirements are fulfilled.

What will you do?

  • Partner with Technical Support, Customer Service, Sales Representatives, Product Managers, and/or customers by email, phone, and/ or in-person to ensure that information and samples necessary to investigate a customer complaint are received.
  • Collaborate with the Customer Quality team in order to perform an impact assessment for a complaint; evaluate and understand how complaint samples compare to established specifications; and review data.
  • Lead customer complaint investigations working with multi-functional teams including Quality Assurance, Engineering, Manufacturing, and Research & Development in order to identify the root cause, corrections, and corrective and preventive actions.
  • Submit work orders and interact with Quality Control in order to evaluate or understand how complaint samples compare to established specifications.
  • Document the root cause, corrections, and corrective and preventive actions in the CAPA System (TrackWise); write a Corrective Action Response (CAR) that contains a summary of the investigation, corrections, and corrective and preventive actions; and utilize the Complaint Management System (SalesForce.com) to both document and communicate the CAR to the customer on behalf of the site.
  • Ensure Management is advised in a timely manner of any significant customer complaints.
  • Analyze complaint trends and facilitate an investigation, root cause analysis, and the identification of corrective actions for products and processes with a cross-functional teams.
  • Support on-site or virtual customer audits as needed.

How will you get here?

Education

  • Bachelor’s degree in related field, or consideration of an equivalent combination of education and experience. Science or Engineering Degree preferred.

Experience

  • At least 2 years’ experience in direct Quality Assurance with experiences collaborating with relevant customers. At least 1 year of proven leadership experience (leading projects) is preferred.
  • Working experience in a regulated (FDA Quality System Regulations (21 CFR Part 820)) and certified International Organization for Standardization (ISO) (13485 or 9001) Quality System strongly preferred.

Knowledge, Skills, Abilities

  • Strong desire to improve product quality and satisfy customer.
  • Ability to multi-task and balance multiple priorities at the same time while focusing and carrying out tasks in a timely and accurate manner.
  • Well organized and structured with strong attention to detail.
  • Ability to work optimally and build and maintain collaborative relationships with individuals and teams across functional boundaries at all levels of the organization and external customers. Able to communicate optimally, both verbally and in writing.
  • Experience interacting with external customers is helpful.
  • Solid understanding of quality tools (DMAIC, Risk Management).
  • Solid understanding of ERP Systems (SAP and/or E1), Complaint Management System (SalesForce.com), CAPA System (TrackWise), and Document Control System (MasterControl and/or Agile) is preferred.
  • Ability to use all of the following PC applications: Microsoft Word, Excel, and PowerPoint.

At Thermo Fisher Scientific, each one of our 80,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Posted
10/04/2021
Salary Range
$64,000.00 - 90,000.00
per Year
Salary range estimated by
Location
Rochester, NY 14600, US
Apply Now