Lead Manufacturing Specialist 1 - Production Quality
- Maintain, update, and improve the Quality Management System documentation, including quality manuals, procedures, work instructions, and forms.
- Understand and translate applicable regulatory, customer, and industry standards into QMS requirements.
- Define and track quality and compliance metrics (e.g., defects, audit findings, on-time CAPA closure, customer complaints).
- Lead the preparation, maintenance, and surveillance for ISO certifications (for example, ISO 9001, AS9100, ISO 14001, ISO 45001 as applicable).
- Coordinate Management Review meetings: prepare inputs, track outputs, and ensure actions are closed.
- Provide regular status reports to leadership on QMS performance, risks, and improvement opportunities.
- Develop an annual audit plan; lead and perform internal audits across functions; train and coach internal auditors.
- Serve as main point of contact for certification bodies, customers, and regulatory auditors. Coordinate logistics, evidence, and responses.
- Record, investigate, and track nonconformities from audits, customer feedback, and internal findings.
- Lead root cause analysis, ensure effective corrective and preventive actions (CAPA), and verify effectiveness.
- Support controlled change to processes and documentation to maintain compliance and traceability.
- Conduct assessments and audits to gauge compliance with applicable regulatory, customer, and quality system compliance.
- Partner with support staff and work teams to identify high risk areas and implement sustainable corrective actions.
- Create, revise, and participate in quality system document updates.
- Identify, drive and partner with the teams to implement projects that improve overall production quality and throughput.
- Contribute to the success of product quality team.
- Advise cross functional team on alternative approaches to Engineering activities, when appropriate.
- Ensure quality records are maintained and assure retention compliance in accordance to regulatory and customer requirements.
- Interface with, and provide support to, regulatory authorities, customer representatives, and supplier representatives.
- Review technical documentation with a view to quality and compliance requirements.
- Use LEAN methodologies to drive regulatory compliance, optimize quality systems that support field action, improve product quality and reliability.
- Bachelor's Degree from an accredited college or university (or a high school diploma/GED with a minimum of 4 years quality compliance experience) + minimum of 3 years quality compliance experience
- Demonstrated ability to analyze and resolve problems.
- Ability to document, plan, market, and execute programs.
- Established project management skills.
- Humble: respectful, receptive, agile, eager to learn
- Transparent: shares critical information, speaks with candor, contributes constructively
- Focused: quick learner, strategically prioritizes work, committed
- Leadership ability: strong communicator, decision-maker, collaborative
- Problem solver: analytical-minded, challenges existing processes, critical thinker
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