Quality Engineer I

About the Role

• Provides Quality Engineering support for Operations to ensure Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance.
• Independent contributor.

Key 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.
• Reviews the adequacy and correctness of changes to Bill of Materials (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
• Maintains risk analyses.
• 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 assures adequacy of corrective actions to prevent re-occurrence.
• Effectively communicates and interacts with customers.
• 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.
• Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems.
• 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.
• Provides support to other quality engineers.
• Performs other functions as required.
• Manages a heavy workload while maintaining accuracy.
• Identifies potential roadblocks and provides innovative solutions.
• Operates with a high level of integrity and professionalism.
• Committed to and accountable for achieving goals and objectives.

Requirements & Tech Stack

• Education/Certification: Bachelor’s Degree in Engineering or related field required.
• Experience:
• 2 – 5 years of experience working in a quality engineering role within a regulated industry.
• 0-2 years’ experience in medical device or regulated manufacturing.
• Skills/Competencies:
• Ability to multitask and drive initiatives to completion.
• Competence in the selection and use of Quality Engineering Tools and Techniques.
• Strong communication skills and ability to align with key stakeholders.
• 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.
• Physical Requirements:
• Light work: Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or lift, carry, push, pull, or move objects.
• Visual Acuity: Close vision.
• Travel: Less than 10%.
• Worker is not exposed to adverse environmental conditions.