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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.
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Donaldson is searching for an experienced Sr Quality Engineer to be a Quality core team member supporting our Life Science vertical. Your role will include support for both currently commercialized product as well as rapid growth in design, development, and commercialization of products globally. This business unit serves the Bioprocessing, Biopharma, Medical Devices, Food, Beverage, Microelectronics and Automotive verticals. This position will work closely with the new product quality and supplier quality teams. They will be responsible to safeguard customer satisfaction, achieve Operational Excellence, support capacity and capability growth through a quality management system based on applicable international standards (ISO 9001, ISO13485, 21CFR210, IATF 16949) contributing to maintain current and obtain new businesses, guarantying the continuous improvement cycle and corporate operational goals.
This high impact role will report directly to the Sr. Quality Manager 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. We would prefer someone near our headquarters in Bloomington, MN, this role could require limited amounts of travel.
Role Responsibilities:
Customer Satisfaction
- Works closely with New Product Quality and Supplier Quality to ensure new product designs being transferred in to manufacturing location consider design for manufacturability, including partnership in defining manufacturing control plan strategies.
- Provides leadership expertise and guidance in interpreting multiple government regulations, standards, and guidelines such as IATF, ISO9001, ISO13485, 21CFR, cGMP, GLP, etc.
- Supports KPI and metrics reporting for manufacturing location in responsibility. Including satisfaction from customer service or customer communication portals.
- In case of non-conformity, analyze root cause of the problem and then implement preventive and corrective initiatives, validate effectiveness of actions, and communicate resolution to customer based on Corporate Corrective Action process to contribute to quality behavior.
Quality Management Systems
- Engage people to impact plant quality culture based on applicable international standards (ISO 9001, ISO13485, 21CFR210, IATF 16949) in order to offer products in market competition.
- Build strong relationships with engineering, operations, and other functions, to develop, maintain, and implement processes and tools.
Operational Excellence
- Own Quality deliverables related to Design Transfer and Design for Manufacturability as a part of the Life Science teams expanding capabilities in bioprocessing and medical device product manufacturing and quality practices in support of ensuring quality of received materials, operation process and finished product based on Safety, Quality, Delivery and Cost.
- Support manufacturing teams in the validation of those processes and product meets Donaldson and customer requirements during New Production Launches, Assembly line transfers and new facilities addition ensuring corporate operational goals.
- Integrates risk and science-based approaches into all aspects of quality systems, processes, and compliance.
- Provide leadership in resolution of quality problems associated with purchased parts and materials, partnering again with New Product Quality and Supplier Quality as needed.
TRAVEL: Up to 30%
Minimum Qualifications:
- Bachelor’s degree in Science, Engineering, or related medical/scientific field
- 5+ years of professional experience in quality and/or regulatory management systems in a regulated environment
- Experience in a core team member role with high awareness of compliance as a QA/QC organization
Preferred Qualifications:
- Knowledgeable in current regulatory and/or quality certification(s) such as CQA, CBA, CQM, RAC, etc.
- Consistent track record of success in audits, compliance, and interaction with notified bodies
- Demonstrated knowledge and expertise in quality processes and regulatory requirements.
- 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.
- Experience effectively leading diverse teams in a highly virtual environment
- Ability to work collaboratively across multiple sites and functions.
- Excellent interpersonal and communication skills
Key words: quality, regulatory, leader, medical device, bioprocessing, biologics, biopharmaceutical, life sciences, biotechnology
Come make a World of Difference!
Employment opportunities for positions in the United States may require use of information which is subject to the export control regulations of the United States. Hiring decisions for such positions are required by law to be made in compliance with these regulations. Applicants for employment opportunities in other countries must be able to meet the comparable export control requirements of that country and of the United States.
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.
