What are the responsibilities and job description for the Quality Manager position at Viant Medical?
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 will be a key member of the Plant Leadership and responsible for all aspects of the quality systems process and serves as the site Quality leader & Management Representative. The Quality Manager will have 9-10 direct reports and oversight of quality team of 20 plus associates. The Orchard Park Site is in growth mode with nearly 300 associates across 2 buildings in a 24x7 operation. The Quality Manager will report to the VP Quality Assurance and Regulatory Affairs.
Main Responsibilities:
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.
The Quality Manager will be a key member of the Plant Leadership and responsible for all aspects of the quality systems process and serves as the site Quality leader & Management Representative. The Quality Manager will have 9-10 direct reports and oversight of quality team of 20 plus associates. The Orchard Park Site is in growth mode with nearly 300 associates across 2 buildings in a 24x7 operation. The Quality Manager will report to the VP Quality Assurance and Regulatory Affairs.
Main Responsibilities:
- Strategic leadership on all regulatory affairs and quality assurance programs and policies.
- Serve as the Management Representative of the quality system and be the interface with Notified Body’s and FDA
- Leading quality assurance team in the design, provision, and maintenance of systems for document and data change control, training, corrective and preventive action, discrepancy handling, product release, environmental monitoring, and complaint handling.
- Leading quality assurance and regulatory affairs functional review and approval of quality system documentation.
- Working in a collaborative fashion with plant leadership team in the pursuit of adherence to documented processes and the development and attainment of key performance indicators.
- Interacting with customers and suppliers on all quality matters.
- Directing the selection, training, and development of the quality team.
- Receiving, interpreting, and implementing corrective action procedures.
- Oversee the internal/external audits and CAPA programs.
- 4 years leadership experience in medical device or other regulated industry in manufacturing environment (Aerospace- Automovile - Food Industry) and Bachelor's degree.
- Experience within a contract manufacturing is preferred
- Demonstrated experience leading a high functioning team, strong people management skills, knowledgeable of quality systems, SPC, statistics, GMP, GLP and exceptional ability to thrive in collaborative, result oriented environment.
- Demonstrated experience and strong knowledge with Lean Manufacturing & Lean Six Sigma methodologies (Green Belt is preferred)
- Strong understanding and experience with FDA and ISO-13485 regulations/audits
- Medical, dental, and vision benefits-effective on date of hire
- Generous paid time off benefits and 10 paid Holidays
- 3 weeks plus 2 days of PTO
- Company-paid life insurance
- 401k plan with company match
- Low-cost nutrition and mental health visits
- Up to $150-off your gym membership annually
- Discounted Pet Insurances for your furry friends
- Access to individualized financial planning meetings
- Employee Discount Program with savings on electronics, home goods, gym equipment, and more
- Discounted family caregiving support
- Tuition Reimbursement
- Defined Career Path for advancement in role and compensation
- New Hire On-boarding Training Plans
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.
Salary : $115,000 - $125,000
