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 Engineer II will provide support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance.

What you will do:

Adheres to Viant Core 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, Company policies and operating procedures, and other regulatory requirements.
Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
Monitors manufacturing of assigned products, assuring compliance with DMR and quality system requirements and assuring complete and correct Device History Records are maintained.
Lead product and process improvement initiatives.
Lead the development, completion, and maintenance of risk analyses.
Under guidance from senior engineer's/quality manager supports the generation and completion of protocols and reports for product, process, and test method validations.
Interfaces with Manufacturing Engineers to review processes for new and existing products and supports the coordinate of process validations and capability studies under the guidance of senior quality professionals/quality manager.
Lead the development various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, implementation, and training of Incoming, In-Process, Manufacturing instructions, and Final Inspection procedures.
Lead the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
Conducts complaint investigations and remediation recommendations as needed.
Lead CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
Assists with product transfers

What You Need:

BS degree in a related discipline and 2+ years of relevant experience, or High School Diploma with 10+ years of relative experience
Experience in the medical device industry is strongly preferred
Experience with Quality Management System (IQMS) and Minitab (Preferred)
Experience with Microsoft programs
Ability to apply statistical tools (i.e. Gage R&R, Capability Analysis, Anova, etc.)
Ability to conduct root cause investigations, familiar with root cause techniques (i.e. FMEA, Fishbone, 5 Why, 8D)
Experience in ISO13485 industry
Ability to read and interpret drawings
Knowledge of Process Validation (IQ, OQ, PQ, TMV)
Detail oriented with strong organization skills
Ability to work cross functionally and as part of a project team
Self-Motivated and strong ability to adapt to change

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

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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Quality Engineer II