Experis is exclusively partnering with an industry leading and growing company in the Madison, WI area on a direct hire/permanent Quality Assurance Manager position.
We've closely partnered with the company on numerous positions and this person will have the opportunity to be challenged on a daily basis and part of a great team, and work for a company that has an amazing culture, great work/life balance, and strong opportunity for growth.
Our client offers a very generous base salary, great benefits package, and relocation assistance (if needed).
The Quality Assurance Manager is a highly visible position and responsible for leading and managing incoming, QC and QA Engineering to ensure a high level of quality system and regulatory compliance.
This position will be responsible for the functionality of the Quality Management System, coordinating third party audits (FDA, ISO, etc.) and participating in quality related activities related to Design, Process and Post Market Surveillance.
The Quality Assurance Manager takes a leadership role to ensure that quality standards are met for all products being manufactured and distributed.
- Use knowledge of Good Manufacturing Practices (GMP), Quality System Regulation (QSR), ISO13485 and ISO14971 Risk Management to facilitate continuous process improvement of corporate SOPs and supporting documents.
- Work with personnel at other sites globally to harmonize Quality Systems and processes between sites and functions and maintain consistency.
- Ensure corporate processes result in product that meets customer quality expectations, internal quality standards, Food and Drug Administration (FDA) Quality System Requirements (QSR), and other applicable international regulatory requirements including ISO13485, MDSAP, and JPAL.
- Assist in the complaint process, addressing and resolving complaints when required
- Assist in the process used to identify, investigate, and monitor corrective actions and field failures to ensure action has been taken against reported failure problem
- Implement and report quality metrics to monitor the state of compliance and implement corrections and/or improvements accordingly.
- Review product development and design intent to assure quality requirement compliance has been met as established by the FDA by reviewing product quality issues
- Participate in the Quality management team tasks related to planning, budgeting and cross project management team issues
- Ensure quality standards are met for all products being manufactured and distributed in Deerfield.
- Participate in the CA & PA Deerfield program.
- Provide QA support and guidance in areas of Design, Manufacturing and Post Market Surveillance
- Lead external Quality Systems audits and interfaces with external auditors / regulatory bodies as required.
- Assist in product recalls and other regulatory responses as needed.
- Participate on cross-functional teams to develop policies, procedures and resolve problems as they relate to FDA laws and WW regulations.
- Maintain technical competency and remain current in changes in laws, regulations, and in the industry.
- Bachelor's Degree
- 5+ years of experience
- Experience working in a GMP/regulated environment - i.e. medical device, automotive, aerospace
- Working knowledge of FDA Quality System Regulation (21 CFR PART 820 and related), ISO 13485 requirements, ISO14971 Risk Management requirements in a medical device environment is a plus
- Applied technical knowledge of Qualitative and Quantitative data analysis, and statistical tools. Six Sigma GB or CQE preferred.
- Self-starter with demonstrated project management and problem solving skills and able to work both independently and as a member of an integrated, interdisciplinary multi-site team in carrying out assigned responsibilities
- Excellent interpersonal and written communication skills to communicate effectively at all levels within Quality as well as cross functionally with other departments
- Experience managing a team of professional level quality staff
Experis is an Equal Opportunity Employer (EOE/AA)