Quality Manager

About the role

As Quality Assurance Manager you will ensure the highest standards are met in accordance with regulatory requirements and stated standards (ISO & FDA), continuously improve quality reporting processes, and lead the team to maintain and produce timely quality-assurance results. You will control, review, and challenge quality associates on customer standards to ensure compliance by providing advice and support.

Responsibilities

• Responsible for site regulatory compliance
• Ensure maintenance and implementation of Quality Systems and training
• Act in conjunction with Plant Manager as technical contact on quality-related issues
• Address customer concerns, applying root-cause analysis and problem-solving skills
• Aid in development of suppliers and implementation of Quality Systems Documentation, including training documentation and providing appropriate training
• Lead audits by Third-Party Registrars/Customers
• Fully support and work with all departments to ensure quality standards are upheld
• Provide leadership within daily QA activities and promote a Quality culture throughout the facility
• Support utilization of ISO and QMS systems cost-effectively
• Utilize APQP/PPAP, process flow maps, FMEAs, control plans, and measurement system evaluations to support Quality Standard requirements
• Ensure Quality documentation is current with Corrective Actions (PFMEA, Control Plans, Flow Charts, etc.)
• Manage and report key Quality Performance Metrics
• Work with other disciplines to ensure the integrity of an ISO Class 8 cleanroom
• Promote company Core Values with key focus on Safety
• Read and interpret engineering drawings and quality specifications
• Prepare quality inspection procedures and investigate and resolve quality problems
• Manage customer and third-party quality audits as required
• Manage and/or perform direct internal quality audits
• Act as liaison with customers on quality issues
• Communicate company Quality Objectives to all employees
• Assist with other various duties as assigned by management

Requirements

• Must possess a degree in Science or Business or similar, with 3–5 years’ experience in Quality Assurance in a manufacturing environment
• Thorough understanding and working knowledge of ISO 9001:2015 and ISO 13485:2016 standards
• Certified Lead Auditor
• Experience managing third-party regulatory and customer audits
• Thorough understanding of QA/QC theory, procedures and practices, including potential failure modes for company product lines
• Basic understanding of manufacturing processes and operation systems
• Strong communication, presentation, and analytical skills
• Ability to negotiate and communicate successfully at all levels
• Strategic planning and development skills
• Extensive knowledge of measuring/test equipment, gauging practices, and capability of undertaking full GR&Rs
• Working knowledge of computers, software applications (Word, Excel, Visio, Access, Outlook), and excellent reading/comprehension skills

Qualifications

• ISO Certification: 2 years (Preferred)
• Quality Assurance: 3 years (Preferred)
• Manufacturing: 3 years (Preferred)
• Bachelor’s degree (Preferred)