Quality Assurance Manager

Viant Medical Inc.; Massachusetts; On-site; USD 90,000 - 130,000; Full time

Job summary

A leading medical device manufacturer is seeking a Quality Manager to spearhead their Quality Engineering and Assurance efforts. This role involves managing a team, ensuring compliance with standards, and improving product quality. The ideal candidate will have extensive experience in quality management and regulatory environments, along with strong leadership and problem-solving skills.

Benefits

Medical, dental, and vision benefits

Company-paid life insurance and disability benefits

Generous Paid time off

401k Plan with Company Match

Tuition Reimbursement

Pet Insurance

Home Ownership Program

Qualifications

• 5+ years of experience in a regulated industry.
• 5+ years of Quality Management leadership experience.
• Extensive experience with FDA and ISO regulations.

Responsibilities

• Manage the Quality Team to meet organizational goals.
• Oversee and coordinate quality improvement initiatives.
• Host audits including customer and FDA inspections.

Skills

Communication

Problem-Solving

Leadership

Interpersonal Skills

Education

Bachelor's Degree

Master’s Degree in Engineering or Quality Management

Job description

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

As Quality Manager, the primary purpose of this job is responsibility for the planning, and management of a Quality Engineering Group, which includes Quality Engineering and Quality Assurance.

Essential duties and responsibilities:

• Adheres to Viant’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, ISO Standards, Company policies and operating procedures, and other regulatory requirements.
• Maintains safe and ethical business practices and adheres to Viant’s Quality Policy.
• Manages the Quality Team to meet Site & Organizational goals and customer expectations.
• Collaborates with cross functional organizations to facilitate successful execution of lean initiatives, production plans and Product Development Process.
• Oversees, coordinates and supports the Continuous Improvements, Control Plans, Quality Plans and Validations using statistical methods relevant to manufacturing processes.
• Provides ongoing metrics communications and support to Plant Management toward attainment of objectives. Performs corrective & preventive actions so that the customers’ needs are satisfied; directs, plans and implements a comprehensive quality system designed to improve product quality and
• increase customer satisfaction.
• Performs and coordinates qualification activities in accordance with internal processes and to the intent of the Master Validation Process.
• Manages subordinates in a manner that fosters a self-directed and collaborative team approach.
• Coordinates and provides training and mentoring for Quality Improvements to enhance Associate skills, increase awareness and improve productivity.
• Assists in the development and implementation of Quality Objectives.
• Participates and/or Leads Project Teams for the implementation of Enterprise and Site Quality Objectives.
• Supports and Maintains alignment of Site QMS Documents with QMS Enterprise Policies.
• Serves as the Management Representative.
• Hosts internal and external audits including Notified Body (ISO), Customer and FDA.
• Interviews, hires, and establishes training plans for direct reports.
• Provides leadership regarding development of individuals’ goals and mentoring of the group.
• Performs other functions as required.

The successful candidate will possess:

• 5+ years of experience in a regulated industry (Medical - Aerospace- Automotive)
• 5+ years of Quality Managment leadership experience
• Bachelor's degree required; Master’s degree in Engineering, Quality Management, or a related field preferred.
• Extensive experience with FDA, ISO-13485, ISO-9001 and other relevant regulations.
• Experience within a contract or OEM manufacturing (Preferred)
• Proven track record of successful regulatory audits and compliance.
• Demonstrated experience leading and interacting with customers and suppliers.
• Demonstrated experience leading high-functioning teams and driving continuous improvement using Lean Six Sigma methodologies.
• Exceptional communication and interpersonal skills.
• Strong problem-solving abilities and decision-making skills.
• Results-oriented with a track record of achieving key performance indicators (KPIs).
• 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

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.