Quality Manager

SUMMARY:

The position 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. He/she 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 chemicals list
• Maintains vendor 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
• 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
• 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
• Manage and create reports for key Company measurables and provide feedback on performance at Management Review meeting
• Manage customer required dose audits and clean room testing for sterile packaging
• Determine FAL requirements and capability studies
• Assist engineering with validations

MARGINAL / LESS ESSENTIAL JOB FUNCTIONS:

• Advise management in matters pertaining to quality management system requirements and continuous improvement
• Work with other departments, as a team member, to aid improvements for the entire organization
• Promote and encourage the utilization of programs and teams providing an improved, harmonious working atmosphere
• Additional responsibilities, as required

QUALIFICATION REQUIREMENTS:

• High school degree, or equivalent, required

• Bachelor's degree in quality-related field, or equivalent experience, 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 Power Point, in addition to Mini-Tab
• Knowledge of and experience using hand-held measuring devices, including micrometers and calipers, required

Current Openings for Quality Manager Jobs at XXX DO NOT USE XXX WishBone Medical, Inc

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