The Quality Manager will be based in Buffalo Grove, IL (near Chicago) and is responsible for Regulatory and Quality Systems and will support the Quality Compliance team and site organization to conform and comply with regulations, internal policies, directives and procedures in order to achieve and exceed the quality objectives expected by the customer and the organization.
We are looking for someone who demonstrates:
- Intense collaboration
- Passionate customer focus
- Thoughtful, fast, disciplined execution
- Tenacious commitment to continuous improvement
- Relentless drive to win
Here is a glimpse of what you’ll do:
- Manage a team of quality analysts/technicians
- Run Change Control meetings with department managers.
- Support the site's Quality Compliance team to assure the conformance of all organization's regulatory and quality systems requirements.
- Engage in External Audit Processes (Customers', Regulatory, Government Agencies, etc.).
- Verify the proper implementation and effectiveness of the applicable Regulations, Standards, Policies, Directives and Level 1 Procedures in the organization.
- Provide support to any area that requires help to implement regulatory and quality requirements into their processes.
- Conduct training programs for internal users in subjects related to Regulations or Quality Systems.
- Participate as a key member for all external audits activities and maintain records as required.
- Follows up on internal and external corrective actions to ensure timely implementation and validate their effectiveness
Here is some of what you’ll need (required):
- Bachelor’s Degree and 7 years of experience in Quality or equivalent combination of work and education
- Must have Medical Device experience.
- Experience managing and motivating a team.
- Demonstrates advanced/thorough knowledge of Regulatory and Quality Audits Process
- Regulations and Quality Standards (ISO9001, TL9000, ISO/TS16949, AS9100, ISO13485, ESD20.20, etc.)
- Experience with Internal Quality Systems Manuals and Level 1 Procedures
- Understanding of manufacturing processes and regulatory agencies.
- Ability to define problems, collect data, establish facts and draw valid conclusions.
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
- Strong MS Office skills
Here are a few of our preferred experiences:
- American Society for (ASQ) Certified Quality Engineers Certification
Here are a few examples of what you’ll get for the great work you provide:
- Full range of medical benefits, dental, vision
- Life Insurance
- Matching 401K
- Tuition Reimbursement
- Employee discounts at local retailers
QualityFlex does not accept unsolicited resumes from headhunters, recruitment agencies or fee based recruitment services. Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. Flex does not discriminate in employment opportunities or practices based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status or any other status protected by law. Flex provides reasonable accommodation so that qualified applicants with a disability may participate in the selection process. Please advise us of any accommodations you request to express interest in a position by e-mailing: email@example.com. Please state your request for assistance in your message. Only reasonable accommodation requests related to applying for a specific position within Flex will be reviewed at the e-mail address. Flex will contact you if it is determined that your background is a match to the required skills required for this position. Thank you for considering a career with Flex.