Quality Manager at Jobot
Bellevue, NE 68005
About the Job
Direct Hire Opportunity with Full Benefits. Come Join our growing organization.
This Jobot Job is hosted by: Brooke Meyer
Are you a fit? Easy Apply now by clicking the "Quick Apply" button
and sending us your resume.
Salary: $80,000 - $130,000 per year
A bit about us:
We specialize in design, engineering and manufacturing of electronic products.
Why join us?
Job Details
Introduction: A leading Product Development and Contract Manufacturing firm located in the Midwest is looking for a Quality Assurance Manager with solid Quality Assurance experience. Specifically, we are seeking a self-motivated leader who will direct the development, implementation and administration of the firm’s quality assurance and regulatory compliance systems, programs, and activities. The person will be the Management Representative and the primary contact for all external bodies on quality-related matters.
Job Responsibilities:
1. Lead compliance activities over the life-cycle of the medical and electronic devices and incorporate the latest risk management principles into our existing approved ISO 13485:2016 and 9001:2015 QMS.
2. Ensure compliance with ISO 13485 as well as other applicable standards for medical devices.
3. Ensure compliance with ISO 9001 for electronic devices.
4. Be responsible for updating the QA related files and maintaining the link through the life cycle of product design to post-market surveillance.
5. Contribute actively with inputs for product device documentation requirements, from user needs and applicable standards, to design verification and testing.
6. Monitor and maintain agreements in keeping with global regulatory requirements.
7. Be responsible for all site-related audit activities including internal & external audits, RCCA, CARS, Supplier Approval, and First Article integrity.
8. Manage supplier quality program with support from Supply Chain functions.
9. Organize and coordinate the Management Review process for Top Management’s review of the QMS as per global regulatory requirements.
10. Compile, analyze, and present QMS metrics.
11. Work with Design Engineering to fulfill customer contractual requirements relating to quality requirements as flowed down from the customer agreements (i.e. IQ/OQ/PQ, PPAP, FMEA, capability studies, gage studies) and participate in ECO reviews.
12. Manage and direct Quality Assurance personnel for the site.
Job Knowledge Skills and Abilities: Generally, requires a bachelor's degree in a scientific discipline with a minimum of six years experience in quality assurance/regulatory affairs in the design, development, and manufacturing of medical and non-medical products, to include previous management experience in quality assurance, experience in conducting review audits and hands-on experience with ISO 13485:2016 preferred. Will consider ISO9001:2015 or AS9100.
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
This Jobot Job is hosted by: Brooke Meyer
Are you a fit? Easy Apply now by clicking the "Quick Apply" button
and sending us your resume.
Salary: $80,000 - $130,000 per year
A bit about us:
We specialize in design, engineering and manufacturing of electronic products.
Why join us?
- Opportunity for growth and advancement
- Benefits
- Collaborative work environment
- Stability
- 401 K match
- PTO
Job Details
Introduction: A leading Product Development and Contract Manufacturing firm located in the Midwest is looking for a Quality Assurance Manager with solid Quality Assurance experience. Specifically, we are seeking a self-motivated leader who will direct the development, implementation and administration of the firm’s quality assurance and regulatory compliance systems, programs, and activities. The person will be the Management Representative and the primary contact for all external bodies on quality-related matters.
Job Responsibilities:
1. Lead compliance activities over the life-cycle of the medical and electronic devices and incorporate the latest risk management principles into our existing approved ISO 13485:2016 and 9001:2015 QMS.
2. Ensure compliance with ISO 13485 as well as other applicable standards for medical devices.
3. Ensure compliance with ISO 9001 for electronic devices.
4. Be responsible for updating the QA related files and maintaining the link through the life cycle of product design to post-market surveillance.
5. Contribute actively with inputs for product device documentation requirements, from user needs and applicable standards, to design verification and testing.
6. Monitor and maintain agreements in keeping with global regulatory requirements.
7. Be responsible for all site-related audit activities including internal & external audits, RCCA, CARS, Supplier Approval, and First Article integrity.
8. Manage supplier quality program with support from Supply Chain functions.
9. Organize and coordinate the Management Review process for Top Management’s review of the QMS as per global regulatory requirements.
10. Compile, analyze, and present QMS metrics.
11. Work with Design Engineering to fulfill customer contractual requirements relating to quality requirements as flowed down from the customer agreements (i.e. IQ/OQ/PQ, PPAP, FMEA, capability studies, gage studies) and participate in ECO reviews.
12. Manage and direct Quality Assurance personnel for the site.
Job Knowledge Skills and Abilities: Generally, requires a bachelor's degree in a scientific discipline with a minimum of six years experience in quality assurance/regulatory affairs in the design, development, and manufacturing of medical and non-medical products, to include previous management experience in quality assurance, experience in conducting review audits and hands-on experience with ISO 13485:2016 preferred. Will consider ISO9001:2015 or AS9100.
- Bachelor’s degree in a scientific discipline.
- Knowledge of ISO 13485 and ISO 9001:2015.
- Minimum of 8 years’ experience overseeing a Quality Management System
- Strong overall communication and interpersonal skills.
- Ability to take initiative, maintain confidentiality, meet deadlines, and work in a team environment is essential.
- Ability to work effectively in a culturally diverse work group.
- Ability to lead projects across multiple disciplines.
- Change agent with the ability to influence at all levels of the organization.
- Proficiency with Microsoft Office
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
Salary
80,000 - 130,000 /year