Donaldson is committed to solving the world’s most complex filtration challenges. Employing innovation and breakthrough solutions, we are advancing filtration for a cleaner world. We look for the best people to help us succeed, offering opportunities to learn, effect change, and make meaningful contributions at work and in our communities. This is a place where you can make a world of difference.
Donaldson is searching for an experienced Quality Engineer II, Advanced Product Development to drive the central Quality function supporting our Product & Technology team for our new Life Sciences business unit. This business unit serves the Bioprocessing, Biopharma, Medical Devices, Food, Beverage, Microelectronics and Automotive verticals. Your role will include enhancement of a quality management system that can be adapted for the design, development and commercialization of products globally manufactured for the business identified above. This position will work closely with the new product, supplier and plant quality organizations.
This high impact role will report directly to the Quality Manager, Advanced Product Development of Life Sciences and be an integral member of the team. In this highly visible role, you will also be extensively interfacing with both internal and external stakeholders to position Donaldson for future growth. Although we would prefer someone near our headquarters in Bloomington, MN, this role could also be a remote position.
Role Responsibilities:
- Works on product and process development teams supporting the design and commercialization of new products for Life Sciences
- Involved in solving complex technical problems in a hands-on manner, working in a fast-paced environment
- Influences corporate Advanced Product Development policy and procedure content for the Life Sciences business unit with a focus on application to our bioprocessing and medical device component products
- Collaborates with Product & Technology to develop product concepts, influence design specifications and provide Design for Manufacturability input to the engineering print package
- Oversees regulatory material compliance activities and ensures all applicable laws, regulations and standards, good business practices and company documented procedures are adhered to during product and process development.
- Reviews product eligibility and certification requirements for EPA, FDA and other government regulatory bodies that may claim applicability to Donaldson products
- Supports development and review of process validation strategies and related quality management system deliverables including test method validation
- Integrates risk and science-based approaches into all aspects of quality systems, processes and compliance
- Supports compliance auditing and tracking, including the shared audit management process
TRAVEL:
Up to 25% Domestic and International
Minimum Qualifications:
- Bachelor’s degree in Science, Engineering, or related medical/scientific field
- 3 years of professional experience in quality and/or regulatory management systems in a regulated environment such as bioprocessing, biopharma, medical devices, or food & beverage
Preferred Qualifications:
- Knowledgeable in current regulatory and/or quality certification(s) such as CQA, CBA, CQM, RAC, etc.
- Demonstrated knowledge and expertise in quality processes and regulatory requirements, minimally ISO 9001
- FDA 21 CFR part 820, ISO 13485, ISO 9001, ISO 14971, 21CFR117
- Skilled at taking strategic initiatives and translating them into tactical solutions
- Ability to independently identify and resolve complex problems through good decision quality, functional and scientific technical skills
- Ability to work collaboratively across multiple sites and functions
- Excellent interpersonal and communication skills
Key words: quality, regulatory, medical device, bioprocessing, biologics, biopharmaceutical, life sciences
Come make a World of Difference!
Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.
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