Principal Quality Engineer

Viant Medical Inc.; Laconia (NH); On-site; USD 85,000 - 120,000; Full time

Job summary

Viant Medical Inc. seeks a Quality Engineering Principal to lead quality initiatives and ensure compliance with FDA and ISO standards. The role involves overseeing quality engineering teams, promoting continuous improvement, and driving product quality for medical devices. This position is crucial for enhancing customer satisfaction and operational excellence.

Benefits

Medical, dental, and vision benefits

Company-paid life insurance and disability benefits

Generous Paid time off and 10 paid Holidays

401k Plan with Company Match

Tuition Reimbursement

Pet Insurance

Qualifications

• 8+ years experience in medical device or regulated industry.
• Experience with FDA and ISO 13485 is a plus.
• 3+ years Project Management experience.

Responsibilities

• Lead Quality Engineering, managing teams to meet customer expectations.
• Ensure compliance with FDA Quality System Regulations and ISO 13485 standards.
• Facilitate training on quality control strategies.

Skills

Quality Engineering

Problem Solving

Continuous Improvement

Regulatory Submission

Project Management

Education

BS degree in Engineering

Quality Engineering certification (CQE)

Tools

Microsoft Office

Minitab

eQMS (ETQ-Reliance or Master Control)

Job description

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

Job Purpose:

This role will lead the Quality Engineering, Quality Engineering Technician, and Supplier Quality Engineering resources to meet and exceed Customer expectations with regards to Quality, Cost, Delivery, and Responsiveness. You will plan, coordinate, and direct Quality Engineering and Supplier Quality Engineering to support established Internal and External standards. This will include promoting and organizing training activities related to quality and product acceptance.

The Quality Engineering Principal will be expected to provide support to operations, interact with customers (inclusive of metric/KPI reviews), and provide support for Engineering, Quality Systems, and Process Engineering. This position will be integral in meeting the Quality Management System requirements. This role requires organization and accountability while working with operations and (NPD) new product development teams to ensure compliance to the Quality Manual, Production Control, Supplier Management, and other appropriate procedures for a variety of medical devices from concept through market introduction.

Job Responsibilities:

Leadership:

• Exhibits the Viant Medical Values (Teamwork, Customer Oriented, Be Agile, Integrity, Own It, Servant Leadership)
• Provide Quality Engineering direction, analysis, and recommendations for product development to successfully launch new products into active production in a timely and cost effective manner inclusive of efficiencies with Site growth and expansion tactics.
• Cross-functional leadership: lead and collaborate with cross-functional managers or leaders (Production, Quality, Engineering, Human Resources, Supply Chain, etc.) to drive successful execution of initiatives and Site objectives, fostering a unified "one-team"/ “One-Viant” culture.
• Performance monitoring and development: facilitate consistent one-on-one discussions for all associates under direct supervision, ensuring the documentation of performance goals, creation of individual development plans, and adherence to performance review timelines.
• Lead implementation of continuous improvement projects or as subject matter expert for SPC, FMEA, and process validation
• Lead and provide Project Management support
• With Manager input, oversees the development and training of Quality Engineering, Quality Engineering Technician, and Supplier Quality Engineering to support the Site
• Manage and suggest continuous improvement projects/strategies (based on Site/business needs or metrics) and report plans/updates during Project Governance and Site Management Reviews

Functional Execution:

• Maintain company compliance with FDA Quality Systems Regulations and ISO 13485 standards
• Participates in external/internal audits, management reviews, and other activities covered under Viant Medical’s Quality Manual, Policies, and Procedures
• Hosts training scenarios and training sessions on quality control activities and defect awareness guidance
• Support resources when developing standard methods for inspection, testing, and evaluation utilizing knowledge in related Engineering fields
• Oversee management of MRB and disposition of discrepant material
• Lead trend review and initiate Projects to address root cause
• Leads Correction/Corrective Actions while assisting in the resolution of complex

Compliance:

• Lead customer related quality and regulatory inquiries through resolution
• Direct support for FDA and ISO inspections and registrations
• Act as Quality Approval for the following:
• Quality plans for new products
• Master Validation Plans for product and process qualification
• Product qualifications/validations prior to release to production
• Document Change Orders during new product introduction/transfers/life of the products
• Adheres to Viant Values and suitably represents Viant’s best interests during Customer engagements and audits
• Complies with all safety and quality requirements
• Supports Viant’s supply chain activities and assists with ensuring procedures are compliant to applicable sections of FDA quality system regulation, ISO 13485 regulation, and relevant Customer Requirements

Job Requirements:

Knowledge/Education:

• BS degree in Engineering, a technical or scientific discipline; or with exception, professional certifications with 8+ years experience
• Quality Engineering certification (CQE) preferred or equivalent body of knowledge in areas which include, but are not limited to Statistics, SPC, Geometric Dimensioning/Tolerancing; Sampling, etc.
• Ability to analyze, understand and effectively communicate this technical material.
• Six Sigma (LSSGB or LSSBB) preferred or equivalent body of knowledge in areas which include, but are not limited to Problem Solving, Continuous Improvement, Operational Excellence
• Supervisory Training; or with exception, 2+ years experience with direct reports
• Strong knowledge in principles, training, and experience in Quality Engineering
• Quality Engineering (qualification/validation, sustaining, change management, root cause analysis)

Job Experience:

• 5-10 years experience in the Medical Device or other regulated industry, such as Aerospace, automotive or pharmaceutical
• Experience with FDA and ISO 13485 Certification inspections is a plus
• 3+ years Project Management Experience, supervising diverse teams
• Excellent internal and external customer service skills
• Regulatory submission and support skills (with relevant QMS navigational skills to gather requested files)
• Robust problem solving skills
• Understanding of Lean Manufacturing philosophies
• Strong written and verbal communication skills
• Ability to work well collaboratively and/or independently with fellow team members and leaders
• Attention to detail and organization skills
• Contract Review
• Personnel development and management
• Computer skills with proficiency in Microsoft Outlook, Microsoft Office, Minitab (preferred), eQMS (ETQ-Reliance or Master Control preferred)

Physical Requirements:

• Excellent vision and hand-eye coordination
• Occasional periods of bending, lifting, and standing
• Occasionally required to lift up to 50 lbs
• Flexible schedule will be required to meet business needs, some overtime, weekend, and on call hours may be required
• Must be able and willing to wear personal protective equipment as required including:
• Protective gowning (Safety Shoes covers, apron, hairnet, gloves)
• 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

#INDHP

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.