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QA Scientist 4 - IVD Medical Devices

Fitchburg, WI 53711

Posted: 11/09/2022 Employment Type: Direct Hire/Perm Job Category: QA/Automation Job Number: 528670 Is job remote?: No Country: United States

Job Description

Our Team: The Product Quality Assurance team is a dedicated group focused on supporting our diverse product portfolio. Our main goal is to collaborate effectively with the Operations teams we support to ensure our processes and procedures consistently produce high quality product for our customers.

Your Role: As a QA Scientist 4, IVD Medical Devices, you will be responsible for supporting many of our current GPR, Class 1 and Class 2 in vitro medical device reagent products. In addition to supporting on market product, you will be responsible for providing guidance and support on cross-functional teams in the development of new regulated products in accordance with ISO13485, US FDA 21CFR820, European IVDR and other country specific regulatory requirements as applicable.

Your Experience: We are looking for a candidate with proven design control experience in a regulated environment to help support this growing area of our business. Experience with supporting regulatory submissions including 510K or PMA is preferred.

JOB OBJECTIVE: Assure product quality and compliance to quality system requirements (QSR) pertaining to the manufacture of in vitro diagnostic medical devices.

1. Work independently and with cross-functional teams to assure QSR compliance with applicable regulations (US FDA 21CFR820, Europe IVDR, Health Canada regulations, MDSAP requirements, ISO 13485, etc.).
2. Review and assist in the development of reports, protocols, and SOPs for new and current products.
3. Execute the following activities when appropriate:

a. Review and approve batch records, stability data and validation results to ensure that products meet requirements.
b. Review and approve technical literature content for accuracy and consistency.
c. Assess the scope and inventory impact of nonconforming product situations; approve disposition plans of inventory product on hold and assist in the disposition planning for nonconforming product.

4. Demonstrate leadership within the Product Quality Team.
5. Act as QA lead on new product development cross-functional teams.
6. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
7. Embracing and being open to incorporating the 6 Emotional & Social Intelligence (ESI) core principles in daily work.
8. Understands and complies with ethical, legal and regulatory requirements applicable to our business.

1. Bachelor of Science degree in life science or chemistry.
2. Minimum of 7 years’ experience that includes time spent working in Medical Device industry. Experience must be in manufacturing, process development, quality control or quality assurance.
3. Five (5) years Working knowledge of ISO13485 requirements. Direct experience working in an FDA regulated system.
4. Proven ability to work constructively with a broad range of people, backgrounds, and functions.
5. Ability to apply effective critical thinking skills in complex problem solving and decision making to achieve positive results.
6. Ability to develop concise, clear written communication and presentations that contain both analysis and possible solutions.
7. Ability to effectively prioritize and manage workload in an environment with frequent interruptions and changing priorities and timelines.
8. Experience leading department or corporate projects in a positive team environment.
9. Proficiency with basic word processing and spreadsheet software.

1. Direct experience in quality field related to in vitro diagnostic medical devices.

1. Ability to remain stationary for several hours at a time.
2. Ability to use computers for several hours at a time.

Salary Range: $85-$130k/year. Salary will be commensurate with experience.
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