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