Quality Engineer

New employees are eligible for the following benefits effective date of hire!

• 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 

If you are a motivated and innovative Quality Engineer looking to make a difference in the medical device industry, we invite you to apply for this exciting opportunity to join our dynamic team.

 Viant is a leading manufacturer of medical devices committed to improving patient outcomes through innovative products and solutions. With a focus on quality, reliability, and technological advancement, we strive to meet the evolving needs of healthcare professionals and patients worldwide. As we continue to expand our customer base and develop new products, we are seeking a talented Quality Engineer to join our team.

The Quality Engineer primary purpose of this job is to 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. This position also encompasses a wide range of activities including QMS support, engagement in Continuous Improvement initiatives with cross-functional teams, validation and process verification, as well as supporting customer facing activities. There is a large focus on New Product Introduction at the site, and this position will integrate within engineering teams to develop and document new process production documentation in a hands-on approach.

Essential duties and responsibilities
•    Adheres to Viant Core Beliefs 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 while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.
•    Implements various product and process improvement methodologies.
•    Review the adequacy and correctness of changes to Bill of Materials (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
•    Maintains risk analysis.
•    Completes protocols and reports for test method validation.
•    Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.
•    Develops various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.
•    Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence. 
•    Effectively communicate and interact with customers.
•    Participate in internal audits as a Lead Auditor
•    Completes complaint investigations.
•    Executes plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
•    Assists with product transfers.
•    Executes capability studies and applies statistical quality control which includes Cpk, DOE, Hypotheses Testing, etc.
•    Coordinates the preparation of Quality Plans, including inspection, test and gauge requirements for new product introductions
•    Performs other functions as required

Qualifications
•    Bachelor’s degree in a technical field with 2-5 years applicable experience or
•    Associate’s degree in a technical field with 5-10 years of applicable experience
•    Ability to multitask and drive initiatives to completion
•    Competence in the selection and use of Quality Engineering Tools and Techniques, with focus on Root Cause/Corrective Action, DMAIC and CAPA.
•    Strong communication skills and ability to work in a team environment.
•    Strong knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. FDA 21CRF820, ISO 13485:2016, QSR, etc.)
•    Proficient in Microsoft Office and Minitab
 

It is impossible to list every requirement for, or responsibility of, any position.  Similarly, we cannot identify all the skills a position may require since job responsibilities and the Company’s needs may change over time.  Therefore, the above job description is not comprehensive or exhaustive.  The Company reserves the right to adjust, add to, or eliminate any aspect of the above description.  The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.