Engineer III, QA

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

LOCATION/DIVISION SPECIFIC INFORMATION

This position is located at the Rochester location 75 Panorama Creek Dr. Rochester NY 14625 within the Laboratory Plastics Essentials (LPE) Business Unit of the Laboratory Products Division (LPD).

DESCRIPTION:
As a Quality Engineer III youll help ensure quality excellence and regulatory compliance across manufacturing operations. Youll help ensure our products meet the highest standards while supporting our mission to enable customers to make the world healthier cleaner and safer.

We are looking for a self-driven resourceful Quality Engineer with demonstrated experience driving and sustaining improvement to products while ensuring that those products manufactured meet internal customer and regulatory requirements. Under the direction of the Senior Manager Quality Assurance this position isresponsible for executing the customer facing processes which include Complaint Management Quality Agreements and Audit Support as per the Quality System to ensure that the product or process quality requirements are fulfilled.

KEY RESPONSIBILITES

• Interact 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 (and credit or replacement product is issued to a customer for confirmed complaints).

• Interact with Customer Quality team in order to perform an impact assessment (severity occurrence and detection) for a complaint; evaluate and understand how complaint samples compare to established specifications; and review data to determine if a complaint is an isolated incident or a systemic issue.

• Lead customer complaint investigations working with cross-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 () to both document and communicate the CAR to the customer on behalf of the site.

• Ensure Management is informed 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.

• Influence site quality goals and objectives based on Customer complaints. Act as a subject matter expert when determining clarifications and compliance to written standards providing additional information to the site to ensure consistent application of the Customer Complaint Management processes.

• Maintain and update the Customer Complaint Management process to ensure compliance with current regulations and standards.

• Manage and support the customer quality agreement process and questionnaire requests (which includes maintaining and updating the supplier qualification package).

• Lead and manage the on-site or virtual customer audit process (which includes the assessment scheduling execution and response activities).

• Complies with required quality safety and operation/distribution quality system documents - such as our quality manual and policy good documentation practices plant safety commitments general safety requirements personal protective equipment program and good manufacturing and distribution practices - as applicable.

• Performs other duties as needed.

MINIMUM REQUIREMENTS

• At least 5 years experience in direct Quality Assurance. At least 1 year of demonstrated leadership experience (leading projects) is preferred. Previous experience in a customer facing role is preferred.

• Bachelors degree in related field or consideration of an equivalent combination of education and experience. Science or Engineering Degree preferred.

• Working experience in a regulated (FDA Quality System Regulations (21 CFR Part 820)) and certified International Organization for Standardization (ISO) (13485:2016) Quality System.

• Lead Auditor Certification 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 and detail-oriented.

• Ability to work effectively and build and maintain collaborative relationships with individuals and teams across functional boundaries at all levels of the organization.

• Proven ability to influence internal and external customers and lead changes.

• Ability to communicate effectively both verbally and in writing with internal and external customers; experience interacting with external customers is preferred.

• Ability lead and work on complex issues of moderate scope.

• Ability to act as an advisor/coach to other team members and provide quality guidance to the organization.

• Working knowledge of quality tools (DMAIC Risk Management).

• Working knowledge of ERP Systems (SAP and/or E1) Complaint Management System () 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.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• A choice of national medical and dental plans and a national vision plan including health incentive programs

• Employee assistance and family support programs including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy

• Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan

• Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits please visit: Experience:

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