Viant, a leading manufacturer of medical devices, is looking for a contract Quality Engineer I to join their Indianapolis, IN team. This is a critical role responsible for ensuring that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance in addition to providing work direction for 3-5 Technicians/Inspectors.
- 80,000 sq. ft.
- Two 5-axis CNC machines, six 3-axis CNC machines, thermoforming machine
- FDA registered; ISO 13485 certified
- CNC turning & milling
- Metal forming/bending
- Bachelor’s Degree in Engineering or related field OR 2+ years of experience working in a quality engineering role within a regulated industry
- Competence in the selection and use of Quality Engineering Tools and Techniques
- Strong working knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. FDA 21CRF820, ISO 13485:2016; MDSAP; ISO14971, QSR, MDD, TGA etc.)
- Proficient in Microsoft Office and Minitab
- Knowledge of sheet metal manufacturing
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- 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.
- Leads and 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.
- Leads in the completion and maintenance of risk analysis.
- Leads generation and completion of protocols and reports for test method validations.
- 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.
- Leads and manage complaint investigations.
- Acts as a lead in 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.
- Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Also, leads each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc.
- Coordinates and leads the preparation of Quality Plans, including inspection, test and gauge requirements for new product introductions
- Provides support to other quality engineers.
- Performs other functions as required.
About the company: With over 35 years of medical device molding experience, Viant has become a comprehensive solutions provider for single use medical devices. Services range from concept and design of components to assembly of finished products. They are headquartered in Foxborough, MA and operate 17 manufacturing facilities in the US, with additional locations in China, Mexico, Costa Rica, Puerto Rico, France, Germany and the UK.
All qualified applicants will receive consideration for employment without regard to the individual's race, color, sex, national origin, religion, age, disability, genetic information, status as a military veteran or any other characteristic protected by applicable law.