Senior QA Manager - Salem
By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. At Integer, our values are embedded in everything we do. Customer We focus on our customers' success Innovation We create better solutions Collaboration We create success together Inclusion We always interact with others respectfully Candor We are open and honest with one another Integrity We do the right things and do things right The primary purpose of this position is to assure quality manufacturing of medical devices and components by providing oversight of applicable quality assurance processes, establishment of technical direction, and the management of a team of Quality Assurance Engineers and Technicians. This position serves as the site Management Representative, accountable for the establishment and execution of a quality management system as defined by Integer's Quality policies, FDA QSR, ISO 13485, and the Medical Device Directives. This position will leads and supports quality improvement across the organization. 1. Adheres to Integer's Values and all safety and quality requirements including, but not limited to:
Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements. 2. Develops, maintains and improves the quality management system to ensure compliance to the FDA Quality System Regulation, international requirements such as ISO 13485, and ensures production of finished products meet quality requirements. 3. Develops and maintains auditing processes, procedures and activities to maintain compliance with quality standards and customer requirements. 4. Manages, directs and advises on the establishment of site documentation and procedures including document control and records required for traceability of products though out the business unit. 5. Leads and directs the site Quality function to assure successful new product design transfer and post-market surveillance by collaborating with the Operations, R&D, NPI, Commercial, and Regulatory functions. 6. Directs the continued review of quality activities and the creation of new or revised processes to ensure quality improvements reduce costs and enhance efficiency. 7. Aligns Quality function resources with site productivity efforts while ensuring all product quality and quality system compliance requirements are met. 8. Provides ongoing communications and supports Plant Management toward attainment of Business Unit and Integer Financial and Operational Objectives. 9. Creates a strong and accountable Quality team through the coaching and leading of supervisory staff, and the hiring and planned development of team members. 10. Maintains effective working relationships with internal and external customers and vendors to establish quality standards prior to initial production, and to resolve technical and business related quality issues post-production. 11. Establishes and manages departmental strategic, tactical plans, and metrics. Additionally this function establishes and manages budget to support Quality function and Category team requirements. 12. Promotes interdepartmental coordination and communication to ensure successful execution of Operations Quality Strategy. 13. Acts as site Management Representative. 14. Performs other functions as required. Job Requirements Minimum Education:
Bachelor's degree in Engineering, Math or Statistics. Master's degree preferred. Minimum
Experience:
10-12 years of experience in a technical function with 5 years in managerial experience. Specialized Knowledge:
Prior experience as a Quality Management Representative preferred. Special Skills:
Experience with ISO, GMP, and related quality systems. U.S. Applicants:
EOE/AA Disability/Veteran.
Salary Range:
$200K -- $250K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements. 2. Develops, maintains and improves the quality management system to ensure compliance to the FDA Quality System Regulation, international requirements such as ISO 13485, and ensures production of finished products meet quality requirements. 3. Develops and maintains auditing processes, procedures and activities to maintain compliance with quality standards and customer requirements. 4. Manages, directs and advises on the establishment of site documentation and procedures including document control and records required for traceability of products though out the business unit. 5. Leads and directs the site Quality function to assure successful new product design transfer and post-market surveillance by collaborating with the Operations, R&D, NPI, Commercial, and Regulatory functions. 6. Directs the continued review of quality activities and the creation of new or revised processes to ensure quality improvements reduce costs and enhance efficiency. 7. Aligns Quality function resources with site productivity efforts while ensuring all product quality and quality system compliance requirements are met. 8. Provides ongoing communications and supports Plant Management toward attainment of Business Unit and Integer Financial and Operational Objectives. 9. Creates a strong and accountable Quality team through the coaching and leading of supervisory staff, and the hiring and planned development of team members. 10. Maintains effective working relationships with internal and external customers and vendors to establish quality standards prior to initial production, and to resolve technical and business related quality issues post-production. 11. Establishes and manages departmental strategic, tactical plans, and metrics. Additionally this function establishes and manages budget to support Quality function and Category team requirements. 12. Promotes interdepartmental coordination and communication to ensure successful execution of Operations Quality Strategy. 13. Acts as site Management Representative. 14. Performs other functions as required. Job Requirements Minimum Education:
Bachelor's degree in Engineering, Math or Statistics. Master's degree preferred. Minimum
Experience:
10-12 years of experience in a technical function with 5 years in managerial experience. Specialized Knowledge:
Prior experience as a Quality Management Representative preferred. Special Skills:
Experience with ISO, GMP, and related quality systems. U.S. Applicants:
EOE/AA Disability/Veteran.
Salary Range:
$200K -- $250K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
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