Sr. Quality Engineer

The Senior Quality Engineer assists in the development and operation of quality control systems, application and analysis of testing and inspection procedures, the ability to use metrology and statistical methods to diagnose and correct improper quality control practices, an understanding of human factors and motivation, facility with quality cost concepts and techniques, and the knowledge and ability to develop and administer management information systems and to audit quality systems for deficiency identification and correction

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 9001-2015 (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

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

• Six Sigma Green Belt
• ASQ Certified Quality Engineer (CQE) preferred:
• Familiarity with production processes, standard mechanical, metallurgical and electrical test methods, SPC, ISO-9001-2015 requirements.
• Must possess a strong sense of urgency, teamwork, keen attention to detail, ability to plan, organize and multi-task.

• BS in Engineering (Quality or Industrial Preferred) or related field of study
• 3+ years of experience in a similar role
• Quality management systems experience (ISO 9001:2015 Preferred)