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Quality Engineer Ii, Quality Management Systems

Company

Donaldson
Address , Bloomington, Mn
Employment type FULL_TIME
Salary
Expires 2023-07-26
Posted at 11 months ago
Job Description
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.
Follow Us on LinkedIn:
https://www.linkedin.com/company/donaldson/
Donaldson is searching for an experienced Quality Engineer II, Quality Management Systems to lead the central Quality Systems function for our new Life Sciences business unit, serving the Bioprocessing, Biopharma, Medical Devices, Food, Beverage, Microelectronics and Automotive industries. Your role will development, implementation and maintenance of a quality management system that can be adapted by global multifaceted manufacturing locations 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 Director, Quality Management System of Life Sciences and be an integral member of the leadership 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:
  • Establishes a common set of quality analytics to proactively monitor quality management systems including audits, documentation control, training
  • Supports the internal auditing activities to ensure alignment with internal procedures and policies
  • Maintains the company in a perpetual state of inspection readiness relative to US and international regulations
  • Builds world-class, scalable quality systems and processes across multiple manufacturing sites, geographies, and industries
  • Supports monitoring regulatory compliance changes and ensures all applicable laws, regulations and standards, good business practices and company documented procedures are adhered to
  • Oversees the design and implementation of a global Quality Management System
  • Provides leadership expertise and guidance in interpreting multiple government regulations, standards, and guidelines such as IATF, ISO9001, ISO13485, 21CFR, cGMP, etc. to extended product development and manufacturing teams
  • Oversees and manages compliance auditing and tracking, including the shared audit management process
  • Integrates risk and science-based approaches into all aspects of quality systems, processes and compliance
  • Supports development, implementation and management of quality training and education programs
TRAVEL: Up to 5%
Minimum Qualifications:
  • 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
  • Bachelor’s degree in Science, Engineering, or related scientific field
Preferred Qualifications:
  • Excellent interpersonal and communication skills
  • 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
  • Demonstrated knowledge in quality processes and regulatory requirements such as ISO 9001, ISO 13485
  • Knowledgeable in current regulatory and/or quality certification(s) such as CQA, CBA, CQM, RAC, etc.
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.