The Quality Assurance Manager will direct quality functions including management of technicians and engineering staff who support inspections, plans, tests, nonconformance, and QMS processes.
Responsibilities
Develop department training plans and a Standard of Work to ensure QMS processes are understood and followed. Align department talent and structure with business needs.
Form strong partnerships and work cross-functionally with internal stakeholders in Manufacturing Engineering, Operations Management, Supply Chain, Design Engineering, and Supplier Quality to resolve manufacturing issues.
Lead the Nonconformance Management process to document and disposition of suspect materials. Initiate containment, root cause analysis, and corrective/preventive action activities with cross-functional teams to mitigate the recurrence of defects.
Gather and analyze defect data to provide Pareto analysis, first pass yield, and other KPI's to monitor the process and drive continual improvement projects.
Develop incoming inspection plans and product sampling processes commensurate with high volume manufacturing and risk of the product or material.
Develop and drive the adoption of Quality Control Plans to ensure products meet internal quality system standards and customer requirements.
Develop and drive process validation activities to support NPI, management of change processes, and process control
Train employees on Problem-solving methodologies through classical & experimental design methods by using 6 sigma approach.
Assist the Director in the implementation and adoption of ISO 9001-compliant processes
Manage and facilitate the root cause & corrective actions system through tracking and validation of issues and support in root cause analysis through facilitating brainstorming, use of fishbone diagrams, 8D methodologies, CAPA and design of experiments, etc.
Knowledge, Skills, and Abilities
Knowledge and application of standard quality processes and core tools such as PPAP, MSA, PFMEA, Control Plan, Process Validation, SPC, etc.
Development and delivery of training packages for various quality functions to employees.
Specific training and demonstrated success in applying quality problem solving methods such as fishbone diagrams, 8D methodologies, CAPA, DoE, etc.
Knowledge and experience working within ISO 9001 and/or other applicable ISO standards.
Competence in using ERP, CRM, EQMS, and PLM systems is preferred, but not required.
Strong leadership and ability to work cross-functionally with all levels of the organization.
Education and Experience
Bachelor's degree in engineering or other applicable field of study, or equivalent experience required.
5 years of experience in management role with industrial/manufacturing engineering, supplier management, manufacturing processes, and quality in a regulated industry. Automotive, aerospace, or medical device experience preferred, but not required.
Experience with implementing quality systems and processes for products with Hardware and Software complexities from concept through implementation and adoption. Electro-mechanical experience preferred.