The Quality Manager is responsible for administration, maintenance and auditing of LEMO Northwire’s Quality Management System. This includes industry regulations and 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. The position will train and coach on root cause analysis and problem solving with resources to support quality and cost initiatives. The position will coordinate inspection and proper integration of quality tools to improve existing processes, support manufacturing product conformance and new product development activities.
- Ensures continual quality management system process compliance and improvement including ISO 9001, ISO13485, AS9100, ISO14971, LEMO, 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 audits (LEMO USA ISO Management Representative).
- 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 (and/or improve new) 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.
Required Education and Experience:
- Bachelor’s degree in quality, manufacturing, engineering, business or equivalent experience
- 10+ years in manufacturing
- 5+ years of leadership
- 5+ years ISO 13485 (based) quality systems
Preferred Additional Eligibility Qualifications or Certifications:
- 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
Northwire, Inc. is an Equal Opportunity Employer – M/F/D/V