Sr. Quality Engineer en ARCH Global Holdings LLC

Summary
Responsible for implementing and maintaining ISO 13485 and AS9100 Quality system requirements.

Salary Range: $85,000-$110,000, depending upon experience.

Medical, Dental & Vision effective day one! Competitive 401(k) with employer match and several other benefits offered.

$3,000 sign on bonus. 

Summary
Responsible for implementing and maintaining ISO 13485 and AS9100 Quality system requirements.

Primary Responsibilities

• Lead as the management representative for FDA 21 CFR 820, ISO 13485 and AS9100 certifications.
• Establish and promote a work environment that supports the company Quality policy, Quality objectives and Quality system.
• Develop and implement policies, procedures, and systems that support corporate Quality goals and objectives, and maintain regulatory compliance.
• Provide direction, coaching and development of Quality personnel.
• Lead MRB and CAPA process to reduce product non-conformances through training and effective corrective actions.
• Lead corrective and preventive actions for customer complaints and supplier-related issues.
• Investigate and manage customer complaints with internal and external customers to solve Quality issues through the CAPA process
• Provide leadership on continuous improvement initiatives (lean, Six Sigma, etc.)
• Monitor and report internal and external Quality metrics by collecting, analyzing, and summarizing information and trends.
• Maintain validation and calibration of inspection equipment.
• Organize customer Quality expectation information and contractual obligations.

• Foster and develop a quality system to strive towards achieving zero internal defects ship to customers.
• Incoming, in-process and final inspection support.
• Ensure quality documentation supports compliance with customer, regulatory, and audit requirements.
•  Document control. Assign document control numbers and procedures.  Responsible for managing those activities within the Quality Management System (QMS).  
• Quality system improvement planning and implementation.
• Supplier development, validation, and supplier quality.
• Develop a quality system to ensure all sub-contract manufacturers meet company requirements with a 100% supplier lot acceptance.
• Conducts supplier audits, including qualification of new suppliers.
• New customer Quality Engineering product qualification support.
• Internal process corrective action support.
• Supporting root cause analysis and implementation of corrective action for all process-related concerns.
• Conducts internal and supplier audits, including closing out audit findings, creating audit finding reports and determining proper corrective and preventive actions.
• Preparation of Quality reports.
• Monitor outside service contractor’s capabilities.
• Support inspection prioritization by flagging or escalating customer- or audit-driven requirements.
• Coach inspection and quality staff in preparation for customer audits, external requirements, and regulatory compliance activities.
• Statistical Process Control (SPC). Responsible for data analytics. 

 Qualifications

• Bachelor’s degree
• A minimum of 3 years of progressive ISO 13485 and/or AS9100 Quality assurance experience

• A minimum of 3 years’ experience working in a CNC machining/contract manufacturing company
• Must be a U.S. Citizen or Permanent Resident, due to contractual requirements

Preferred Qualifications

• GD & T experience
• Experience within a precision machining environment 

• Ability to work in a fast-paced environment with multiple priorities
• Experience utilizing problem solving and root cause analysis methods
• High proficiency in use of computer programs including MS Office (Outlook, Excel, Word, PowerPoint) ERP systems (Epicor a plus), etc.
• Experience working with QMS

Additional Notes

ARCH Global Holdings LLC is an Equal Opportunity Employee and wholeheartedly supports diversity in the workplace as a basic premise for business success.  All employees of ARCH Global Holdings LLC are employed on an at-will basis.

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments.

A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.