SUMMARY: The position of Senior Quality Engineer is responsible for the development, implementation, and maintenance of Red Star Contract Manufacturing’s Quality Management System and development of various quality initiatives, as directed. The Senior Quality Engineer is responsible for taking the actions necessary to ensure that inspection assets are utilized correctly and efficiently and are readily available to meet departmental objectives. This position supports a lean and safe manufacturing environment while focusing on continuous improvement, quality, and support of teamwork throughout the company.

ESSENTIAL DUTIES AND RESPONSIBILITIES: (includes the following but other duties may be assigned)

• Maintain FDA registration and ISO 13485 certification
• Maintain the Quality Manual, procedures, and records in accordance with ISO 13485 standard
• Manages the PM program, calibration log, and contact materials list
• Maintains Supplier evaluations and re-evaluations
• Responsible for scheduling and maintaining internal and external quality audit activities, including training and preparation for internal quality auditors. Perform re-audits of nonconformances found during internal or external quality audits to ensure corrective actions have been implemented and are effective
• Responsible for timely processing of Customer Complaints, Change Requests, NCRs, Customer Returns, and CAPA activities.
• Interface with supply chain and suppliers concerning problems with quality and responsible for issuing, monitoring, and follow-up activities for suppliers’ action request (SCAR) to ensure effective corrective action is implemented
• Establish, maintain, and control quality records, as required by ISO standards
• Establish, maintain and support document control activities within the eQMS system
• Ensure high level of internal and external customer service by investigating and correcting customer complaints to product nonconformances, and aid department heads, or their designees, in root cause analysis related to corrective and preventative action issues
• Work with management team and customers to develop and implement quality agreements, control plans, inspection requirements, risk assessments, and training requirements
• Determine FAL requirements and capability studies
• Assist engineering with validations

QUALIFICATION REQUIREMENTS:

• High school degree, or equivalent, required
• Bachelor’s degree in quality-related field, or equivalent experience, preferred
• 5+ years of experience in Quality Engineering within a regulated manufacturing environment (preferred)
• Good command of the English language, oral and written

OTHER SKILLS AND ABILITIES:

• Must have considerable knowledge and experience in the development, implementation, and maintenance of an ISO 13485 compliant QMS
• Must have considerable knowledge and experience in the use of recognized quality tools, including root cause analysis, FMEA, and similar programs
• Skilled in Microsoft Word, Excel, and PowerPoint, in addition to Minitab
• Knowledge of and experience using hand-held measuring devices, including micrometers and calipers, required

• Maintain FDA registration and ISO 13485 certification
• Maintain the Quality Manual, procedures, and records in accordance with ISO 13485 standard
• Manages the PM program, calibration log, and contact materials list
• Maintains Supplier evaluations and re-evaluations
• Responsible for scheduling and maintaining internal and external quality audit activities, including training and preparation for internal quality auditors. Perform re-audits of nonconformances found during internal or external quality audits to ensure corrective actions have been implemented and are effective
• Responsible for timely processing of Customer Complaints, Change Requests, NCRs, Customer Returns, and CAPA activities.
• Interface with supply chain and suppliers concerning problems with quality and responsible for issuing, monitoring, and follow-up activities for suppliers’ action request (SCAR) to ensure effective corrective action is implemented
• Establish, maintain, and control quality records, as required by ISO standards
• Establish, maintain and support document control activities within the eQMS system
• Ensure high level of internal and external customer service by investigating and correcting customer complaints to product nonconformances, and aid department heads, or their designees, in root cause analysis related to corrective and preventative action issues
• Work with management team and customers to develop and implement quality agreements, control plans, inspection requirements, risk assessments, and training requirements
• Determine FAL requirements and capability studies
• Assist engineering with validation