Quality Engineer - Medical Device / Electrical

at  Crown Laboratories Inc

JOB SUMMARY

This position is responsible for maintaining the quality system and for developing innovative solutions to quality related problems. Assures compliance to quality control guidelines and procedures to ensure that incoming materials and finished goods comply with specifications. Assists in the design and implementation of policies and procedures for testing and evaluating the precision and accuracy of products and/or equipment. Assists in Root Cause Analysis/Corrective Actions. Ensures projects are completed on time and within budget. Supports quality assurance team regarding projects, tasks, and operations.

JOB RELATED QUALIFICATIONS / SKILLS:

• Bachelor’s degree in Electronics Engineering required
• Auditing experience in quality assurance requirements associated with medical devices.
• ISO 13485 Certified Lead Auditor or CQA, preferred.
• Understanding of inputs, outputs, raw materials, waste, quality control, costs, and techniques for maximizing the manufacture and distribution of goods.
• Strong project management skills as well as an ability to multi-task.
• Ability to write reports, business correspondence and procedure.
• Ability to respond internally to common inquires or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, groups and /or boards of directors
• A minimum of five years of quality engineering experience, preferred.
• A minimum of three years of experience in the medical device preferred.
• Thorough knowledge of FDA Quality System requirements, ISO 13485:2016 (Quality System) requirements, ISO 14971:2019 (Risk Management) requirements, Medical Device Regulation (MDR) requirements, and Current Good Manufacturing Practices (cGMP).
• Preferred experience with IEC 62304 Software Lifecycle requirements
• Proficiency with Microsoft Office products, including Excel, Word, PowerPoint, and Outlook
• Experience with ETQ – Reliance, preferred
• Experience with ROSS (ERP) system preferred
• Excellent attention to detail and communication skills (written and oral)
• Good analytical and statistical problem-solving skills / tools.
• Strong ethical standards
• Travel up to 10%.
  NOTE: This job profile is intended to provide an overview of expected job duties and requirements. It is not intended to be a contract of employment, explicit or implicit. All contents are subject to change at the sole discretion of the company. Cooperation is expected of all employees. Other duties may be assigned as needed.

• Support company goals and objectives, policies, and procedures in compliance with quality systems, FDA regulations and all other external regulatory requirements for which product is distributed
• Assesses, provides recommendations, and leads implementation of systems, processes and equipment for improvement and compliance to cGMP and ISO 13485:2016 within the Operations, Quality and Regulatory processes. Provides written reports and supporting documentation for recommendations
• Provides quality engineering support to manufacturing/kitting, along with support for new product launch and/or transfer
• Develop and implement quality control process sampling systems (skip-lot), procedures, and statistical techniques.
• Performs statistical analysis of data and write technical reports.
• Ensure accurate project schedules are maintained and communicated.
• Support other quality functions which may include QA/QC sampling plans, supplier development, and quality training initiatives
• Present data analysis and trend information to management and other groups as required.
• Responsible for the corrective action report process (CAPA).
• Manage and track the corrective action reports to ensure action(s) are taken in a timely manner.
• Responsible for reviewing and investigating customer complaints received per MDR’s, FDA, and ISO requirements.
• Investigate reported product problems and complaint activity trends related to supplier quality.
• Review of customer complaint investigations & trend analysis to identify corrective action opportunities.
• Ensure Non-conformance process is followed per procedure and provide technical input, identify & develop solutions to recurring issues, along with communication to the nonconformance team.
• Support internal/external/corporate audits
• Evaluate data and identify trends related to Nonconformance/Quality Holds as needed. Collaborative to develop innovative solutions and communicate to management
• Lead problem solving efforts to identify and resolve recurring and new quality issues to ensure production of safe and effective medical devices.
• Works collaboratively with Operations and R&D project teams to develop and implement appropriate risk management, qualification, verification, and validation plans.
• Support Document Control initiatives and consult on continuous improvement activities involving the document control program. Assist with eQMS activities.
• Manage activities and procedures associated with the Device Master Record (DMR) and Device History File (DHF). Support all activities with the batch records/device history record (DHR)
• Assist with maintaining the Risk Management Files and participate in Risk Analysis of changes. Lead efforts with completing a full risk assessment of the receiving, kitting, and shipping of products (PFMEA/Risk Analysis)
• Assist with maintaining and management the Software Lifecycle requirements per IEC 62304
• Strong background in electronics design and analysis, with the ability to read and interpret schematics, conduct root cause analysis on circuits, and determine power and amperage requirements for various projects.
• The employee may be asked to perform other tasks related to his/her competence.