Job Summary

The Senior Quality Manager is a strategic leader responsible for the overall Quality Management System (QMS) and the quality performance of our products and processes. This role goes beyond traditional QC/QA; it is about embedding quality into the DNA of the company. You will be responsible for developing quality strategy, leading a team of quality professionals, and interfacing with senior leadership to ensure that quality objectives align with and support business goals. The ideal candidate is a proactive leader, an effective change agent, and a subject matter expert in quality principles and regulations.

Key Responsibilities

Strategic Leadership & Business Integration:

Develop, implement, and communicate the long-term quality strategy and roadmap for the organization.
Establish and monitor Key Performance Indicators (KPIs) and metrics to measure the effectiveness of the QMS and report on quality performance to the executive team.
Integrate quality principles into all business processes, from design and development to supply chain management and customer service.
Champion a culture of continuous improvement and quality excellence throughout the organization.

Quality Management System (QMS) Oversight:

Own, maintain, and continuously improve the company's QMS, ensuring compliance with all applicable standards (e.g., ISO 9001, ISO 13485, IATF 16949, AS9100).
Lead all internal and external audits, including regulatory and certification body audits. Serve as the primary management representative.
Manage the CAPA (Corrective and Preventive Action) program, ensuring robust root cause analysis and effective, timely resolutions.
Oversee the management review process, prepare and present data on QMS performance to senior management.

Team Leadership & Development:

Lead, mentor, and develop a high-performing team of Quality Engineers, Analysts, and Inspectors.
Foster a collaborative environment where the quality team is seen as a valuable partner to engineering, manufacturing, and operations.
Manage resource allocation, budget, and professional development for the quality department.

Risk Management & Compliance:

Proactively identify and mitigate quality risks across the product lifecycle and supply chain.
Ensure compliance with all relevant domestic and international regulatory requirements (e.g., FDA, EU MDR, FAA).
Oversee the supplier quality management program, including audits, performance monitoring, and development.

Process Improvement & Customer Focus:

Utilize Lean, Six Sigma, and other process improvement methodologies to drive efficiency, reduce waste, and improve product quality.
Act as a central point of contact for critical customer quality issues, ensuring swift and effective resolution and communication.
Analyze customer feedback and field data to identify trends and drive preventative actions.

Required Qualifications & Experience

Bachelor's degree in engineering, Life Sciences, Business Administration, or a related field. Master's degree preferred.
10+ years of progressive experience in a quality role, with at least 5+ years in a quality management or leadership position.
Proven track record of successfully implementing, maintaining, and improving a QMS that is certified to a recognized standard (e.g., ISO 9001, ISO 13485).
Extensive experience leading and hosting external audits (e.g., FDA, Notified Body, Registrar).
Demonstrated experience in leading and developing a technical team.
In-depth knowledge of quality core tools (APQP, PPAP, FMEA, MSA, SPC).
Strong financial and business acumen, with experience managing a department budget.
Excellent communication, presentation, and interpersonal skills, with the ability to influence at all levels of the organization.
Certified Quality Manager (e.g., CQM, CMQ/OE) or similar professional certification is highly desirable.

Preferred Qualifications

Experience in Electricals manufacturing industry.
Expertise in specific regulatory requirements., 21 CFR Part 820, 21 CFR Part 11, EU MDR, ASPICE).
Proven expertise in Lean Six Sigma (Black Belt or Master Black Belt certification strongly preferred).
Experience with quality in a new product development (NPD) environment.
Hands-on experience with modern Quality Management Software (QMS) and ERP systems.

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