Job Opening: Quality Engineer

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

• cument 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

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