Position Summary:Responsible for implementing and maintaining ISO 13485 and AS9100 Quality system requirements.
Primary Responsibilities- Provide direction, coaching and development of Quality personnel.
- 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.
- Foster and develop a quality system to strive towards achieving zero internal defects ship to customers.
- Lead MRB and CAPA process to reduce product non-conformances through training and effective corrective actions.
- 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.
- Organize customer Quality expectation information and contractual obligations.
- Participate in creation of DMR. Specifically assure the development of part specific inspection plans to meet customer requirements and contractual obligations.
- Develop robust, part specific, inspection processes that meet customer requirements.
- Analyze failures, corrective, and preventive actions to respond to customer inquiries.
- Incoming, in-process and final inspection support.
- Ensure timely resolution of supplier failure, corrective actions, and preventive actions.
- 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.
- Interface with Engineering and Operations to ensure internal transfers of new products are in accordance with approved data.
- Preparation of Quality reports.
- 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
- Due to contractual requirements, this position is subject to the International Traffic in Arms Regulations (ITAR) which requires U.S. person status. ITAR defines U.S. person as an U.S. Citizen, U.S. Permanent Resident (i.e. 'Green Card Holder'), Political Asylee, or Refugee.
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 NotesThis 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.
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