ESSENTIAL DUTIES AND RESPONSIBILITIES
- Formulates and maintains quality assurance objectives and coordinates objectives with production procedures in cooperation with the Manager of QA to maximize product reliability and minimize costs.
- Devises sampling procedures, and designs and develops forms and instructions for recording, evaluating and reporting quality and reliability data consistent with company policies and procedures.
- Works with Materials/Purchasing Department to assure acceptable supplier quality and delivery.
- Works with Staff Managers and Sales/Marketing to assess customer satisfaction and address/resolve issues.
- Plans, promotes, and organizes training activities related to product quality and reliability.
- In conjunction with the Quality Manager, serves as a representative & directs ISO 9001-2008 (ANSI/ASQC Q9001-1994)
- Lead product and process risk assessment
- Knowledge of SPC, FMEA, MSA, and Control Plan development
- Ability to work with team to gather information to write Validation Protocols, Final Reports, Master Plans for Process Validation and Product Qualifications
- Conduct data collection, data analysis, and trending
- Assist and/or lead in thorough investigations of quality issues and effective corrective and/or preventative action
- Lead product scale-up for process capability and statistical relevancy
- Expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production and process controls; Corrective & Preventive Action (CAPA), complaints & risk management; product quality improvement and root cause analysis
EDUCATION and/or EXPERIENCE:
- BS in Engineering (Quality or Industrial Preferred) or related field of study
- 5+ years of experience in a similar role
- Quality management systems experience (ISO 9001)
- Experience with PPAP, PFMEA, GD&T
