Job Description

Description

The main responsibilities within the role of the Quality Assurance Manager will be to ensure the highest standards are met in accordance with regulatory requirements and/or stated standards (ISO & FDA); to continuously improve our quality reporting processes; to manage the team to ensure quality assurance results are maintained and produced in a timely manner; to control, review and challenge our quality associates on customer standards to ensure compliance by providing advice and support.

The ideal candidate will be required to read and interpret engineering drawings and quality specifications, to 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; and work closely with all departments to build a Quality Team.

Key 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 the 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
• Assist with other various duties as assigned by management

Job Qualifications:

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

Experience:

• ISO Certification: 2 years (Preferred)
• Quality Assurance: 3 years (Preferred)
• Manufacturing: 3 years (Preferred)

Education:

• Bachelor's (Preferred)

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