Viant Medical Inc.
We’re a company of agile, customer-oriented individuals with a shared commitment to integrity, servant leadership, and teamwork. Our associates take pride and ownership in their work, and innovate to provide the highest quality, life-enhancing medical technology in the world. Together, We’re in It for Life.
The Quality Manager is a key member of the Plant Leadership team and serves as the site Quality leader and Management Representative, overseeing all aspects of the quality systems process in an FDA and ISO 13485 regulated medical device environment. This highly responsible role requires strong leadership, customer relations, and organizational skills, managing a team of 20+ associates (including 7 direct reports) at our three buildings.
Responsibilities:
Support and uphold Viant Values: Customer Oriented, Integrity, Servant Leadership, Own It, Teamwork, and Be Agile.
Provide strategic leadership for all quality assurance and regulatory programs, ensuring continuous improvement and compliance with FDA, ISO 13485, and customer requirements.
Lead the design, implementation, and maintenance of systems for document control, training, corrective and preventive action, discrepancy handling, complaint handling, product release, and environmental monitoring.
Review and approve quality system documentation; develop and maintain procedures for QA and regulatory functions.
Collaborate with plant leadership and corporate quality to drive adherence to processes and achieve KPIs.
Manage quality engineering support and indirect inspection teams to improve efficiency and resolve root causes.
Interact with customers and suppliers on all quality matters, ensuring strong relationships and satisfaction.
Handle direct selection, training, and development of quality personnel; coach and mentor team members.
Oversee internal/external audits, CAPA programs, and implement corrective actions to improve product quality.
Communicate and act on revisions, validations, and quality-related requirements; ensure robust QMS and customer satisfaction.
Manage and communicate all quality-related information, including revisions, validations, audits, and customer requirements.
Interpret and implement corrective actions to address product quality issues as requested by customers.
Maintain a robust Quality Management System that meets all FDA, ISO 13485 and customer requirements.
Perform other duties as needed
Requirements
Bachelor’s degree in Engineering, Quality, or related field.
5+ years of experience in Quality Assurance and Regulatory Affairs within medical device manufacturing or any regulated industry (Automotive or Aerospace)
Strong knowledge of ISO 13485, FDA, and Corrective Action Plans processes.
Experience with internal/external audits and maintaining a robust Quality Management System.
Knowledge of CMM programming and inspection systems.
Ability to read and interpret blueprints and technical drawings.
Proficiency in MS365 applications (Word, Excel, PowerPoint).
Experience Oracle and IQS proficiency (Required).
Experience with Power BI (user level) (Preferred).
Experience and knowledge with statistical systems as Minitab for statistical analysis
Demonstrates excellent written and verbal communication skills, enabling clear and effective interaction across all organizational levels.
Applies structured problem-solving methods to address complex challenges and adapt to situations with limited standardization.
Exhibits strong leadership and people management capabilities, including coaching, mentoring, performance evaluation, and team development.
Physical Requirements:
Performs light, non-strenuous administrative activities on a regular basis.
Occasionally lifts up to 20 lbs. and carries up to 10 lbs.; may involve minimal bending, pushing/pulling, crawling, climbing, balancing, or standing for extended periods.
Maintains manual dexterity to handle and manipulate small items effectively.
Requires visual acuity to distinguish colors, assess spatial relationships, and focus on fine details (e.g., using microscopes or similar equipment).
Travel:
Minimal overnight travel (up to 10%) by land and air.
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
We offer market competitive compensation. Potential salary range for this role is $115k-$130k. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn.
Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.
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The Quality Manager is a key member of the Plant Leadership team and serves as the site Quality leader and Management Representative, overseeing all aspects of the quality systems process in an FDA and ISO 13485 regulated medical device environment. This highly responsible role requires strong leadership, customer relations, and organizational skills, managing a team of 20+ associates (including 7 direct reports) at our three buildings.
Responsibilities:
Support and uphold Viant Values: Customer Oriented, Integrity, Servant Leadership, Own It, Teamwork, and Be Agile.
Provide strategic leadership for all quality assurance and regulatory programs, ensuring continuous improvement and compliance with FDA, ISO 13485, and customer requirements.
Lead the design, implementation, and maintenance of systems for document control, training, corrective and preventive action, discrepancy handling, complaint handling, product release, and environmental monitoring.
Review and approve quality system documentation; develop and maintain procedures for QA and regulatory functions.
Collaborate with plant leadership and corporate quality to drive adherence to processes and achieve KPIs.
Manage quality engineering support and indirect inspection teams to improve efficiency and resolve root causes.
Interact with customers and suppliers on all quality matters, ensuring strong relationships and satisfaction.
Handle direct selection, training, and development of quality personnel; coach and mentor team members.
Oversee internal/external audits, CAPA programs, and implement corrective actions to improve product quality.
Communicate and act on revisions, validations, and quality-related requirements; ensure robust QMS and customer satisfaction.
Manage and communicate all quality-related information, including revisions, validations, audits, and customer requirements.
Interpret and implement corrective actions to address product quality issues as requested by customers.
Maintain a robust Quality Management System that meets all FDA, ISO 13485 and customer requirements.
Perform other duties as needed
Requirements
Bachelor’s degree in Engineering, Quality, or related field.
5+ years of experience in Quality Assurance and Regulatory Affairs within medical device manufacturing or any regulated industry (Automotive or Aerospace)
Strong knowledge of ISO 13485, FDA, and Corrective Action Plans processes.
Experience with internal/external audits and maintaining a robust Quality Management System.
Knowledge of CMM programming and inspection systems.
Ability to read and interpret blueprints and technical drawings.
Proficiency in MS365 applications (Word, Excel, PowerPoint).
Experience Oracle and IQS proficiency (Required).
Experience with Power BI (user level) (Preferred).
Experience and knowledge with statistical systems as Minitab for statistical analysis
Demonstrates excellent written and verbal communication skills, enabling clear and effective interaction across all organizational levels.
Applies structured problem-solving methods to address complex challenges and adapt to situations with limited standardization.
Exhibits strong leadership and people management capabilities, including coaching, mentoring, performance evaluation, and team development.
Physical Requirements:
Performs light, non-strenuous administrative activities on a regular basis.
Occasionally lifts up to 20 lbs. and carries up to 10 lbs.; may involve minimal bending, pushing/pulling, crawling, climbing, balancing, or standing for extended periods.
Maintains manual dexterity to handle and manipulate small items effectively.
Requires visual acuity to distinguish colors, assess spatial relationships, and focus on fine details (e.g., using microscopes or similar equipment).
Travel:
Minimal overnight travel (up to 10%) by land and air.
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
We offer market competitive compensation. Potential salary range for this role is $115k-$130k. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn.
Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.
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