Quality Engineer III

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

The Quality Engineer 3 will be expected to provide support to Operations, interact with customers and provide support for Engineering, Quality Systems and Process engineering. Specializations may include but are not limited to: design control; material and process control; product reliability; software quality engineering; and/or metrology.

This position will be integral in meeting the Quality Management System requirements. It requires creativity and foresight to work with operations and product development teams to ensure compliance to the Quality Manual,Design Control, Supplier Management and other appropriate procedures for a variety of medical devices from concept through market introduction. The ideal candidate is a self-motivated individual who is excited by the

prospect of working in a dynamic, fast-paced environment.

Job Responsibilities:

• Maintain company compliance with FDA Quality System Regulations and ISO 13485 standards. Experience with FDA and ISO inspections and registration is a plus
• Actively participates in internal audits, management review and other activities covered under Viant Medical Quality Manual, Policies and Procedures
• Provide customer related quality and regulatory inquiries support
• Compiles and writes training material and conducts training sessions on quality control activities
• Experience with Swiss machinning and automated inspection equipment (CMM / Smart Scope)
• Provide QE direction, analysis and recommendations for Product Development to successfully launch new products into active production in a timely and cost effective manner. Directs development and maintenance of internal/external standards relative toDesign and Development
• Lead implementation of continuous improvement projects or act as subject matter expert for SPC, FMEA, DOE and process validation.
• Lead and provide Project Management support as needed
• Develops and initiates standard methods for inspection, testing, and evaluation, utilizing knowledge in related engineering fields
• Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data
• Performs measurement system analyses to evaluate test and inspection equipment
• Leads disposition of discrepant material and devises process to assess product quality and reliability
• Monitors and directs engineering group on calibration requirements and implementation of systems to support equipment calibration Lead supplier approval and qualification of new/revised items which includes inspection method development and validationas well as correlation with suppliers methods, supplier audits, management of supplier corrective and preventative actions and assist in FMEA Direct support for FDA and ISO inspections and registration Directs workers engaged in measuring, testing, and tabulating data concerning quality and reliability
• Provides mentoring to other Quality Engineers
• All other duties as assigned

Qualifications:

• 4+ years experience in the Medical Device or other regulated industry, such as QSR and ISO 13485, with increasing responsibility
• Experience with FDA and ISO 13485 - Certification inspections is a plus
• 3 plus years Project Management experience, supervising diverse teams
• Must be adept in use of computer software for the analysis of data, preferably Microsoft Excel and statistical packages (Minitab preferred)
• 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, Design of Experiments, etc.
• Ability to analyze, understand and effectively communicate this technical material. Experience with LeanManufacturing and Six Sigma is a plus
• Ability to organize and judge priorities in a dynamic, fast-paced environment and work independently with minimal supervision
• Must possess excellent verbal & written communication skills, which include but are not limited to presentation,organizational and management skills

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

We offer market competitive compensation. Potential salary range for this role is $100-$110k.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.