Quality Specialist

Description

We are seeking a meticulous and proactive Quality Specialist to support and continuously improve our Quality Management System (QMS) in alignment with ISO 9001 standards. This role is critical in ensuring our products and processes meet both customer expectations and regulatory requirements. The ideal candidate will have hands-on experience with quality compliance programs and a solid understanding of environmental regulations such as REACH, RoHS, Proposition 65, PFAS, and POP. Key responsibilities include conducting internal audits, analyzing quality data, identifying trends, and driving corrective and preventive actions to enhance product quality and operational efficiency.

Overall Responsibilities 

• Monitor and uphold quality standards across manufacturing, production, and service processes.
• Conduct inspections, internal audits, and product testing to ensure compliance with internal standards and external Certifications such as ISO 9001 and AS9100.
• Investigate non-conformances and customer complaints, driving effective corrective and preventive actions (CAPA) to address root causes.
• Collaborate with suppliers and customers to ensure full compliance with environmental and regulatory standards (e.g., REACH, RoHS, Proposition 65, PFAS, POP).
• Support process development and improvement initiatives, including first lot-to-stock approvals and optimization of quality procedures.
• Maintain and manage quality documentation, including procedures, work instructions, inspection records, and compliance reports.
• Participate in root cause analysis and structured problem-solving using tools such as Six Sigma, 8D, and Fishbone/Ishikawa diagrams.
• Train and support team members on quality standards, inspection techniques, and regulatory compliance requirements.
• Partner with engineering, production, and supply chain teams to drive continuous improvement and ensure consistent product quality.

Qualifications

• Bachelor’s degree in Engineering, Quality Management, or a related technical field; equivalent work experience will also be considered.
• Minimum of 2 years of experience in quality assurance, supplier quality, or manufacturing quality within a regulated industry.
• Solid understanding of ISO 9001, AS9100, or other recognized Quality Management System (QMS) standards.
• Hands-on experience with quality tools and methodologies such as FMEA, SPC, PPAP, and root cause analysis techniques (e.g., 5 Whys, Fishbone, 8D).
• Proficient in ERP systems, quality management software, and statistical analysis tools (e.g., Minitab, JMP, Excel).
• Strong analytical and problem-solving abilities with a keen attention to detail and a drive for continuous improvement.
• Excellent verbal and written communication skills, with the ability to collaborate effectively across departments and with external stakeholders.
• Certified Quality Engineer (CQE), Six Sigma Green Belt or Black Belt, or similar certifications 
• Proven experience driving continuous improvement      initiatives within quality management systems, including supplier      development, performance monitoring, and sustainability efforts.
• Direct experience managing regulatory compliance      programs, including REACH, RoHS, Proposition 65, PFAS, and related      declaration of compliance activities.
• Demonstrated ability to operate effectively in      both low- to mid-volume and high-volume production environments, adapting      quality strategies accordingly.

Working Conditions:

• This position is primarily based in an office environment with frequent interaction with production, engineering, and quality teams.
• Occasional time may be spent on the manufacturing floor, requiring the use of personal protective equipment (PPE) as needed.
• Standard working hours apply, with occasional flexibility required to support audits, inspections, or production schedules.
• Role may involve sitting or standing for extended periods, working at a computer, and handling physical or digital documentation.
• Minimal travel may be required for supplier audits or off-site training.