Quality Engineer II

Quality Engineer II

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.
• Leads product and process improvement initiatives.
• Leads 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.
• Leads the development of 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.
• Leads 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.
• Leads 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