Quality Manager

Overview

Quality engineering expertise for development projects from inception through market introduction for a broad spectrum of business needs, including design controls, risk management, supplier qualification and process validation to ensure product quality in accordance with regulations, standards and company policies.

• Provide general regulatory affairs guidance to personnel and customers in order to align regulatory affairs expectations with defined Viant responsibilities.
• Provide strategic leadership on all quality assurance programs and policies; strengthen and continually improve company-wide level of internal and external quality. Deliver site level results based on corporate and divisional strategies through tactical implementation.
• Lead quality assurance department in the design, provision, and maintenance of systems for design control, document and data change control, training, corrective and preventive action, discrepancy handling, complaint handling, etc.
• Provide consultation to all departments on application of quality management system requirements.
• Develop and maintain quality system procedures for quality and regulatory department responsibilities.
• Lead quality assurance functional review and approval of quality system documentation.
• Perform Management responsibilities for site level quality personnel, including direction, development and other management responsibilities as assigned.
• Work in a close, collaborative fashion with site management in the pursuit of adherence to documented processes and the development of key performance indicators.
• Interact with customers and suppliers on all quality matters while building and maintaining strong relationships.
• Directs the selection, training, and development of personnel within the limits of company administration policy.

• Coach, mentor, develop, direct, train, and evaluate the work of quality personnel.
• Maintain a robust Quality Management System that meets all FDA, ISO 13485 and customer requirements.
• Ensure customer satisfaction with product conformity/quality.
• Receive and provide communications and related materials and reports regarding parts revisions, parts on hold, questions on dimensions, parts rejections, parts changes, qualifications, validations, internal audit data, and other quality-related information the customer requires.
• Receive, interpret, and implement corrective action procedures for product quality that the customer requires.
• Implement changes in the process/procedures requirements to improve product quality.
• Function as site point of contact for all internal, external and regulatory audits and inspections.

Employee must comply with all safety policies and safe work procedures established by the company.

Note: Job tasks may also involve using personal protective equipment such as safety glasses, goggles, gloves, and other equipment as established in company policies and safe work procedures. Working with cutting & machining fluids, solvents, lubricants and other hazardous chemicals using appropriate safety controls. Employee will be expected to attend safety training, and may serve on the facility safety committee and participate in hazard analysis and resolution.

• Bachelor's degree (Master's desired) in Engineering or applied science (BSME, BSEE or BS Physics preferred) with minimum of 6 years' related experience in a regulated / quality industry, preferably in the medical device industry.
• ASQC certification a plus. Management experience a plus.
• Must have aptitude to develop a functional and technical understanding of products to ensure that manufacturing and inspection processes are adequate to ensure appropriate product performance.

It is impossible to list every requirement for, or responsibility of, any position. Similarly, we cannot identify all the skills a position may require since job responsibilities and the Company’s needs may change over time. Therefore, the above job description is not comprehensive or exhaustive. The Company reserves the right to adjust, add to, or eliminate any aspect of the above description.

The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.

We offer market competitive compensation. Potential salary range for this role is $140,000-$170,000 annual salary. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.