Our client is working to upgrade their quality department and they need a Quality Manager who will take over the administration, maintenance and auditing roles for their Quality Management System. Key to this role is your ability to train and coach on root cause analysis and problem solving with resources to support quality and cost initiatives. Additionally, you will coordinate inspections and proper integration of quality tools to improve existing processes, support manufacturing product conformance and new product development activities. The company serves several industries including medical device, aerospace and industrial equipment and each has their own quality standards. You will oversee continuous improvement in support of defined key process metrics. Management of CAPA (Corrective/Preventive action), NCM (Non-Conforming Materials, Internal Audits and Management Review process.
No visa sponsorship is available for this position now or in the future
What you will be doing:
- Ensures continual quality management system process compliance and improvement including ISO 9001, ISO13485 (MUST HAVE THIS), AS9100, ISO14971, customer, regulatory, and statutory requirements.
- Provide support to maintain compliance to UL and CSA requirements. Maintain Supervised Manufacturers Testing Certification (SMTC). Coordinate compliance to new requirements (national or international) as identified.
- Drives corrective action and root cause closures of failure events for such audits that require corrective actions, findings from internal audits and customer audits. Be the point person for all internal and customer.
- Manage department personnel and coordinate internal resources to support department activity (calibration, return material authorization, first article, gauge R&R’s, incoming inspection, in-process inspection, VQC, electrical inspection and statistical process control).
- Initiates the development and improvement of practices and procedures to promote data collection and in-process inspection in the manufacturing work centers and within the Quality Assurance department activities.
- Initiates the development of supplier quality metrics, map critical supplier performance trends, supplier auditing and provides feedback in advance of non-conforming material events; participates in supplier audits and supplier improvement projects.
- Provide support to product development activities through facilitation of Process Failure Mode Effect and Analysis tool and development of product specific inspection plans.
- Promote an awareness of Quality Assurance goals and processes throughout operations and create an environment committed to continuous, quality improvement.
What they would like to see:
- Bachelor’s degree in quality, manufacturing, engineering, business or equivalent experience
- 10+ years in manufacturing
- 5+ years of leadership
- 5+ years ISO 13485 quality systems (Must have)
Additional preferred experience includes:
- ISO 9001, ISO13485 and/or AS9100 lead auditor
- ISO 14971
- Advanced Product Quality Planning (APQP)
- Certified Quality Manager – ASQ
- Certified Quality Engineer – ASQ
- Production Part Approval Process (PPAP)
- Lean Enterprise
- Health, dental and vision insurance
- 401K with match
- Vacation and holidays
- Tuition reimbursement
- Disability and life insurance
- Assistance with relocation if needed
Let's move your career forward and apply now. We review all resumes and applications submitted. A member of our staff will reach out to you directly if you meet the qualifications for this role.