Quality Engineer

summary Sr. Quality Engineer Summary: Responsible for implementing and maintaining ISO 13485 and AS9100 Quality system requirements. Salary Range: $85,000–$110,000, depending on experience Benefits: Medical, Dental & Vision coverage effective day one, competitive 401(k) with employer match, and additional benefits Primary Responsibilities: Serve as the management representative for FDA 21 CFR 820, ISO 13485, and AS9100 certifications Promote a work environment that supports the Quality policy, objectives, and system Develop and implement policies, procedures, and systems that support corporate Quality goals and regulatory compliance Provide direction, coaching, and development of Quality personnel Lead MRB and CAPA processes to reduce product non-conformances through training and corrective actions Manage corrective and preventive actions for customer complaints and supplier-related issues Investigate and resolve customer complaints with internal and external stakeholders Lead continuous improvement initiatives (Lean, Six Sigma, etc.) Monitor and report internal and external Quality metrics, analyzing trends Maintain validation and calibration of inspection equipment Organize customer Quality expectations and contractual obligations Support incoming, in-process, and final inspections Ensure quality documentation supports compliance with customer, regulatory, and audit requirements #NowHiring Manage document control activities within the Quality Management System (QMS) Plan and implement Quality system improvements Develop and maintain supplier quality, including validation and audits Support new customer product qualification Perform root cause analysis and implement corrective actions for process-related concerns Conduct internal and supplier audits, manage findings, and determine corrective/preventive actions Prepare Quality reports and monitor outside service contractor capabilities Coach inspection and Quality staff for audits and regulatory compliance Perform Statistical Process Control (SPC) and data analytics required-skills: Qualifications: Bachelor’s degree Minimum of 3 years of progressive ISO 13485 and/or AS9100 Quality assurance experience Minimum of 3 years’ experience in CNC machining or contract manufacturing Preferred Qualifications: GD&T experience Experience in a precision machining environment Ability to work in a fast-paced environment with multiple priorities Strong problem-solving and root cause analysis skills High proficiency in computer programs including MS Office, ERP systems (Epicor a plus) Experience working with a QMS

Created: 2025-10-09