Summary
Responsible for implementing and maintaining ISO 13485 and AS9100 Quality system requirements.Salary Range: $85,000-$110,000, depending upon experience.
$3,000 sign on bonus.
Health, dental and vision benefits that start on day 1! Generous 401k match.
Primary Responsibilities
- Foster and develop a quality system to ensure no internal defects ship to customers.
- Analyze failures, corrective, and preventive actions to respond to customer inquiries.
- Incoming, in-process and final inspection support.
- Document control. Assign document control numbers and procedures. Responsible for managing those activities within the Quality Management System (QMS).
- Continuously improving Quality inspection work instructions, processes, and procedures.
- Provide guidance to inspectors in scheduling the priorities of the department.
- Quality system improvement planning and implementation.
- Supplier development, validation, and supplier quality.
- Ensure timely resolution of supplier failure, corrective actions, and preventive actions.
- 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.
- Responsible for assisting with continual improvement activities to enhance the quality system, such as 5S, Kaizen lean methods, etc.
- Interface with Engineering and Operations to ensure internal transfers of new products are in accordance with approved data.
- 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.
- Statistical Process Control (SPC). Responsible for data analytics.
Qualifications
- Bachelor’s degree
- A minimum of 3 years of progressive ISO 13485 and AS9100 Quality assurance experience
- A minimum of 5 years’ experience working as a Quality Engineer
- 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
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.#ARCH123
