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.
