Lab Quality Manager

10 - 12 years

0 Lacs

Pune/Pimpri-Chinchwad Area

Posted:4 days ago| Platform: Linkedin logo

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Skills Required

management development maintenance test documentation consistency compliance audit regulations cybersecurity risk nist data interface testing ethernet interoperability integrity security audits certification analysis lean sigma efficiency reliability controls communication emc evidence resolve training leadership auditing learning collaboration monitoring reporting analyze effectiveness reports spc fmea engineering assessment certifications drive teamwork

Work Mode

On-site

Job Type

Full Time

Job Description

Job Responsibilities: 1. Quality Management System (QMS) Development and Maintenance Develop, implement, and maintain a QMS aligned with ISO/IEC 17025 and other applicable quality standards. Define and enforce quality processes, test procedures, and documentation practices to ensure accuracy and consistency in test results. Conduct regular reviews and gap analyses to assess compliance with sector-specific regulatory frameworks. Oversee the management of quality records, audit logs, corrective actions, and preventive actions (CAPA). 2. Compliance with Sector-Specific Standards and Regulations Ensure compliance with industry standards and regulations across multiple sectors, including: Automotive: ISO 11452, CISPR 25, ISO 7637, SAE J551, ISO/SAE 21434 (cybersecurity), and OEM-specific standards. Cybersecurity: ISO/SAE 21434: Cybersecurity Risk Management for automotive applications. IEC 62443: Industrial control system cybersecurity standards. NIST, ISO 27001: Cybersecurity frameworks for data protection and threat mitigation. Industrial and Commercial: IEC 61000 series, FCC Part 15/18, IEEE standards, and relevant cybersecurity protocols. Military/Defense: MIL-STD-461, MIL-STD-464, MIL-STD-810, RTCA/DO-160. Residential and Consumer Electronics: IEC, FCC, and CE marking standards. Interface Testing: Validation of CAN, LIN, FlexRay, Ethernet, and RF interfaces used in automotive and industrial applications. Ensuring compliance with interoperability, data integrity, and security standards. Stay up to date with changing regulatory requirements and communicate updates to internal teams. 3. Audit, Accreditation, and Continuous Improvement Plan, conduct, and manage internal audits to ensure compliance with ISO/IEC 17025, ISO 9001, and ISO 21434 standards. Prepare the lab for external audits and accreditation assessments by regulatory authorities and certification bodies. Manage the resolution of non-conformities identified during audits through corrective and preventive actions (CAPA) . Lead root cause analysis (RCA) to identify process inefficiencies and implement effective solutions. Promote continuous improvement through Lean, Six Sigma, and other quality methodologies to enhance testing efficiency and reliability. 4. Cybersecurity and Interface Testing Oversight Establish quality protocols for cybersecurity testing in compliance with ISO/SAE 21434, IEC 62443, and NIST frameworks. Oversee penetration testing, vulnerability assessments, and security audits for automotive and industrial systems. Ensure interface validation for CAN, LIN, FlexRay, and Ethernet protocols to meet performance and security benchmarks. Collaborate with technical teams to assess cybersecurity risks and identify threats to system integrity and interoperability. Implement quality controls to ensure that interfaces maintain data accuracy, security, and compliance with sector-specific standards. 5. Customer and Stakeholder Communication Act as the primary point of contact for quality-related concerns, audits, and technical inquiries from clients and regulatory bodies. Collaborate with internal teams to ensure that customer requirements for EMC, cybersecurity, and interface testing are clearly defined and met. Facilitate client audits and ensure that all necessary documentation and quality evidence is available for review. Address and resolve customer complaints related to quality issues, ensuring customer satisfaction and trust. 6. Training, Development, and Team Leadership Develop and deliver training programs to lab personnel on quality management principles, compliance standards, and sector-specific protocols. Conduct specialized training sessions on cybersecurity best practices, interface validation protocols, and quality auditing procedures. Foster a culture of continuous learning and quality awareness , ensuring that all team members understand and follow established quality processes. Lead and mentor the quality team, ensuring effective collaboration and high performance. 7. Data Analysis, Performance Monitoring, and Reporting Analyze quality performance data to identify trends, root causes, and improvement opportunities. Establish and track Key Performance Indicators (KPIs) to assess the effectiveness of quality processes and ensure consistent test results. Generate detailed quality reports for management, highlighting audit findings, risk assessments, and corrective actions. Utilize statistical tools such as SPC, Pareto analysis, and FMEA to improve lab performance and test reliability. 8. Risk Management and Preventive Action Implement risk management frameworks to identify, assess, and mitigate quality-related risks across testing operations. Conduct Failure Mode and Effects Analysis (FMEA) for EMC, cybersecurity, and interface testing to proactively identify and address potential failure points. Develop and enforce contingency plans to manage quality-related disruptions and ensure business continuity. Qualifications and Experience: Education: Bachelor’s degree in Electronics Engineering, Computer Science, Quality Management, or a related technical discipline. Advanced degree (e.g., Master’s in Quality, Engineering, or Cybersecurity) preferred. Experience: Minimum 10-12 years of experience in quality management, preferably in an EMC testing, cybersecurity, or interface validation environment. Proven experience managing quality processes in industries such as automotive, industrial, military, residential, and commercial sectors. Strong knowledge of ISO/IEC 17025, ISO 9001, ISO 21434, IEC 62443, and other relevant standards. Hands-on experience in cybersecurity risk assessment, penetration testing, and interface protocol validation. Track record of successful audit management and regulatory compliance. Certifications: Certified Quality Manager (CQM), ISO 9001 Lead Auditor, or equivalent quality certifications. Cybersecurity certifications (e.g., CISSP, CISM, CEH ) are highly desirable. Six Sigma Green/Black Belt certification is a plus. Skills and Competencies: Technical Expertise: In-depth knowledge of EMC testing methodologies, cybersecurity frameworks, and interface testing protocols. Analytical Skills: Strong data analysis and problem-solving abilities to identify quality trends and drive continuous improvement. Project Management: Ability to manage multiple projects, timelines, and resources effectively. Communication Skills: Excellent verbal and written communication skills, with the ability to engage with internal teams, clients, and auditors. Leadership and Teamwork: Strong leadership skills with the ability to guide and mentor cross-functional teams. Attention to Detail: Commitment to maintaining accuracy, compliance, and quality consistency across all testing processes. Show more Show less

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Millennium Semiconductors
Millennium Semiconductors

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Techville

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