- Provides support ensuring products produced meet the multiple government regulations, standards, and guidelines such as AS9100, IATF16949, 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.
- Engage people to impact plant quality culture based on applicable international standards (ISO 9001, ISO13485, 21CFR210, AS9100, IATF 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.
- Develop quality procedures and work instructions to maintain control of processes.
- Performing internal audits, PPAPs and Gage R&Rs.
- Own 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.
- Provide support in resolution of quality problems associated with purchased parts and materials, partnering again with New Product Quality and Supplier Quality as needed.
- 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
- Working experience with ISO9001, ISO 13485, AS9100 or IATF16949 quality systems.
- Experience working as a team member of a QA/QC organization
- Ability to apply Six Sigma tools and principles such as Process Capability, Gage RR, Design of Experiments, and DMAIC in manufacturing settings
- 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 in quality processes and regulatory requirements
- 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
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Quality Engineer II - Bloomington, United States - Donaldson
Description
Donaldson is committed to solving the world's most complex filtration challenges. Together, we make cool things. As an established technology and innovation leader, we are continuously evolving to meet the filtration needs of our changing world. Join a culture of collaboration and innovation that matters and a chance to learn, effect change, and make meaningful contributions at work and in communities.
Donaldson is seeking a Quality Engineer II to be a Quality core team member supporting our production facility in Bloomington, MN. This business unit serves the Bioprocessing, Biopharma, Medical Devices, Food, Beverage, Microelectronics and Automotive verticals. This position will work both Operations and Product Development 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 contributing to maintain current businesses, guarantying the continuous improvement cycle and corporate operational goals.
This role will report directly to the Sr. Quality Manager of Life Sciences and be an integral member of the team. In this role, you will also be extensively interfacing with both internal and external stakeholders to position Donaldson for future growth.
Role Responsibilities:
Customer Satisfaction
Quality Management Systems
Operational Excellence
Minimum Qualifications:
Preferred Qualifications:
Key words: quality, medical device, bioprocessing, biologics, biopharmaceutical, life sciences
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.
