Quality Engineer III

Viant•Indianapolis, IN

About The Position

The primary purpose of this job is to provide Quality Engineering 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. Independent contributor.

Requirements

Bachelor’s Degree preferred in Engineering or related field required or 5+ years of experience working in a quality engineering role within a regulated industry.
Minimum 5+ years' experience at Quality Engineer level II in medical device or regulated manufacturing.
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
Light physical activity performing non-strenuous day-to-day activities of an administrative nature.
Minimal lifting (20 lbs.), carrying (10 lbs.), bending, pushing/pulling, crawling, climbing, balancing, and prolonged standing.
Manual dexterity sufficient to reach and handle items.
Requires the ability to identify and distinguish colors, judge distance and space relationships (i.e. visualize objects of multiple dimensions), and adjust the lens of the eye to bring an object into sharp focus (microscope, etc.).

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 (BOMs), 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 meets all necessary regulatory requirements and assures the 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. Also, 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.
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.
Conducts raw material inspection.
Oversees in-process inspection.
Utilizes most gauging methods.
Possesses a working knowledge of GD&T.
Leads in executing capability studies and test method validation.
Programs OGP and/or CMM to support automated inspection.
Leads in complaint investigations and CAPA activities.
Provides training (e.g., Inspections and Calibration).
Leads in performing calibration activities
Performs other functions as required.

Benefits

Medical, dental, and vision benefits-effective on date of hire
Generous paid time off benefits and 10 paid Holidays
136 Hours PTO (prorated based on hire date)
Company-paid life insurance
401k plan with company match
Low-cost nutrition and mental health visits
Up to $150-off your gym membership annually
Discounted Pet Insurances for your furry friends
Access to individualized financial planning meetings
Employee Discount Program with savings on electronics, home goods, gym equipment, and more
Discounted family caregiving support
Tuition Reimbursement
On-site Training Programs
Defined Career Path for advancement in role and compensation
New Hire On-boarding Training Plans
Climate Controlled
Clean & Comfortable Setting