Summary
Provides strategic leadership and direction for the Quality organization, ensuring that quality systems, processes, and practices support business objectives, customer requirements, regulatory compliance, and operational excellence. Establishes quality strategy, policies, objectives, and performance expectations and provides leadership across functions to drive continuous improvement, strengthen quality performance, mitigate risk, and support business growth.
Essential Duties and Responsibilities
- Provide strategic leadership and direction for the Quality organization, establishing priorities, objectives, and performance expectations aligned with business and operational goals.
- Lead the development, implementation, and continuous improvement of the site's Quality Management System and associated quality policies, procedures, and controls.
- Serve as the site's senior quality leader and management representative for applicable ISO 9001, AS9100, and ISO 13485 quality management systems.
- Ensure continued compliance with applicable regulatory, customer, industry, and certification requirements, including applicable FDA, ITAR, ISO, and IPC requirements and standards.
- Provide leadership for quality planning related to processes, products, customers, and business requirements, with consideration for broader corporate quality objectives.
- Establish and monitor quality metrics and performance indicators. Identify trends, risks, and systemic issues and lead actions to improve quality performance.
- Provide quality performance, risk, and improvement recommendations to site and organizational leadership.
- Lead the Material Review Board (MRB) process and provide oversight for the disposition and control of nonconforming material and product.
- Provide leadership and oversight for corrective and preventive actions, root cause analysis, and systemic problem resolution in partnership with Engineering, Manufacturing, Supply Chain, and other functions.
- Lead quality improvement initiatives focused on reducing defects, improving process capability, increasing throughput, and strengthening overall operational performance.
- Drive a culture of continuous improvement and quality ownership throughout the organization.
- Provide oversight of internal and external audit activities, certification requirements, customer audits, and resulting corrective actions.
- Partner with Supply Chain and suppliers to evaluate supplier quality performance, address quality risks, and ensure supplier quality systems meet business and customer requirements.
- Oversee the calibration system and applicable preventive maintenance controls to ensure compliance and effectiveness.
- Ensure appropriate training and organizational capability related to workmanship standards, acceptance criteria, quality systems, and regulatory/customer requirements.
- Support environmental management requirements, including applicable ISO 14001 responsibilities and site environmental management activities.
- Partner with Operations, Engineering, Supply Chain, Program Management, and other functions to identify and mitigate quality and operational risks and improve customer outcomes.
- Provide quality leadership and expertise in support of new products, customers, programs, processes, and business opportunities.
- Promote awareness and understanding of regulatory, customer, and quality requirements throughout the organization.
- Lead, develop, and mentor Quality leaders and team members, building organizational capability and ensuring appropriate talent development and succession planning.
- Support corporate and site Lean/6S objectives and integrate quality principles into continuous improvement initiatives.
- Support and follow all applicable Quality Management System requirements related to quality, environmental, health, safety, and security.
- Perform other duties and responsibilities as assigned.
Job Knowledge, Skills & Abilities
- Advanced knowledge of quality management systems and quality principles within a complex manufacturing environment.
- Strong knowledge of ISO 9001, AS9100, ISO 13485, and other applicable regulatory and customer quality requirements.
- Working knowledge of FDA, ITAR, IPC, and applicable electronics manufacturing standards and requirements.
- Demonstrated ability to translate business objectives into quality strategies, priorities, metrics, and improvement initiatives.
- Strong knowledge of corrective action, root cause analysis, risk management, process improvement, and continuous improvement methodologies.
- Ability to analyze quality and operational data, identify trends and systemic risks, and develop effective corrective and preventive strategies.
- Strong business acumen with the ability to balance quality, customer, operational, financial, and business considerations.
- Demonstrated ability to influence decisions and drive results across functions without relying solely on direct authority.
- Strong leadership and organizational capability, including experience building, developing, and leading professional and technical teams.
- Ability to communicate effectively with customers, regulatory bodies, auditors, suppliers, and senior leadership.
- Strong written, verbal, presentation, and executive communication skills.
- Proficiency with Microsoft Office applications and applicable electronic manufacturing and quality systems.
Qualifications
Experience/Education
- Bachelor's degree in Engineering, Quality, Operations, or a related technical discipline required; advanced degree preferred.
- Minimum of 10 years of progressively responsible quality, engineering, or manufacturing experience, including significant leadership responsibility.
- Demonstrated experience leading a quality organization within a complex manufacturing environment.
- Experience managing multiple concurrent technical, quality, and operational priorities.
- Demonstrated experience influencing cross-functional leaders and driving organization-wide quality and continuous improvement initiatives.
- Experience interacting with customers, auditors, regulatory organizations, and senior business leadership.
- Demonstrated balance of strategic thinking, strong analytical capability, and effective execution.
- Strong business judgment, attention to detail, and written and verbal communication skills.
Due to ITAR and / or CUI compliance, this position requires candidates to be a U.S. Citizen.
Benefits Offered: Comprehensive benefit package including medical, dental and vision coverage; company-paid basic life/AD&D insurance, short-term and long-term disability insurance; voluntary supplemental insurances, flexible spending accounts and employee assistance program (EAP). Sick Leave, Vacation Time, and company-paid Holidays are also provided as paid time off. NEOTech also provides a 401(k) Retirement Savings Plan option with a company match.
NEOTech is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.
NEOTech has a long-standing commitment to maintaining a safe, quality-oriented and productive work environment. We also want all employees to perform their duties safely and efficiently, in a manner that protects their interests and those of their co-workers. We recognize that alcohol and drug abuse pose a threat to the health and safety of NEOTech employees and to the security of the Company’s equipment and facilities. For these reasons, NEOTech is committed to the elimination of drug and alcohol use and abuse in the workplace. Candidates being considered for hire must pass a pre-employment background check and drug test which include screening for illegal drugs and marijuana.
