Quality Manager

At Viant, we partner and innovate with our customers to provide the highest quality, life enhancing medical devices in the world.

The Quality Manager coordinates activities and provides daily direction to a team of quality inspectors, quality technicians and other team members to ensure that quality requirements and improvement objectives are achieved, including management of the day-to-day processes around performance management and attendance for each individual in the department.

Job Responsibilities:

• Provide strategic leadership on all regulatory affairs and quality assurance programs and policies; strengthen and continually improve company-wide level of internal and external quality.
• Lead quality assurance department in the design, provision, and maintenance of systems for document and data change control, training, corrective and preventive action, discrepancy handling, and complaint handling.
• Provide consultation to all departments on application of quality and regulatory requirements.
• Develop and maintain quality system procedures for quality and regulatory department responsibilities.
• Lead quality assurance and regulatory affairs functional review and approval of quality system documentation.
• Manage quality engineering support function; indirect support to quality inspection teams who report to quality engineering.
• Work in a close, collaborative fashion with 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 improvement personnel.
• Maintain a robust Quality Management System that meets all FDA, ISO 13485 and customer requirements.
• Ensure customer satisfaction with product 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.
• Oversee the internal/external audits and CAPA programs.

Job Requirements:

• Bachelor's degree in Engineering or applied science (BSME, BSEE or BS Physics preferred)
• +2 years related experience in reliability/quality field, preferably in the medical device industry.
• +2 years experience in a quality management position
• 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.

Preferred Qualifications:

• ASQC certification 
• Critical device experience
• Knowledge/background with metrology - sterility - microbiology
• Ability to communicate in English/Spanish

Physical Requirements:

• Light physical activity performing non-strenuous day-to-day activities of an administrative nature.  Minimal lifting (20 lbs.), carrying (10 lbs.), bending, pushing/pulling, crawling, climbing, balancing, and prolonged standing. 
• Manual dexterity sufficient to reach and handle items. 
• It may require minimal overnight travel (up to 10%) by land and air. 
• Requires the ability to identify and distinguish colors, judge distance and space relationships (i.e. visualize objects of multiple dimensions), and adjust the lens of the eye to bring an object into sharp focus (microscope, etc.).

Skills:

• Strong written and oral communications sufficient to be an effective, persuasive speaker and negotiator; write editorials, journal articles, speeches, manuals, and critiques; and read scientific journals, abstracts, financial reports, and legal documents. 
• Advanced mathematical calculations knowledge included but not limited to: application of theorems, functions, and fundamental concepts in advanced calculus, modern algebra, and statistics.
• Strong knowledge with principles of rational systems to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. 
• Good interpretation of a variety of instructions furnished in written, oral, diagrammatic, or schedule form.
• Basic computer operations (cc mail, record keeping, and routine database activity, etc.) and utilizes advanced features of software packages (word processing, spreadsheet, graphics, etc.)
• Strong knowledge of quality systems, SPC, statistics, GMP, GLP. 
• Strong people management skills (counseling, coaching, evaluating, directing).

Benefits: 

• Medical, dental, and vision benefits-effective date of hire!
• Company-paid life insurance and disability benefits
• Generous Paid time off and 10 paid Holidays
• 401k Plan with Company Match
• Tuition Reimbursement
• Voluntary Universal Life and Long-Term Care
• Voluntary Legal Plan
• Pet Insurance
• Home Ownership Program