Quality Engineer We have an outstanding career opportunity for an experienced Quality Engineer with medical device or related equipment manufacturing experience to join a world leader in the Medical Device Manufacturing industry located in the St. Louis area.We are searching for a Quality Engineer who will be responsible for the implementation and maintenance of effective Quality Systems in accordance with FDA Quality Systems Regulation, ISO 9001, ISO 13485 and other applicable country specific regulations.Top Reasons to Work with Us1.
Fast growing International Company!2. Professional growth opportunity!3.
Employee friendly working environment!What You Will Be DoingResponsibilities include: - Document quality systems and programs in the areas of management responsibility, auditing, quality trends, quality costs, training, validation, design controls, purchasing controls, corrective and preventive actions, process control, customer complaints, calibration, documentation control to ensure compliance with FDA and regulatory requirements.- Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.- Monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.- Review the adequacy and correctness of changes to Bill of Materials (BOMs), Assembly Procedures, Drawings, Component Specification, etc.- Ensure that the disposition non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.- Quality Engineering Support for Design Control Process - Develop and implement project Quality Plan, review and approve to Design Specifications, Design verification and validation protocols, facilitate and participate in design reviews, develop quality-engineering deliverables and assure Design History File (DHF) is updated.
- Participate in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
- Lead continuous improvement projects.What You Need for this Position- Bachelors Degree- 3+ years work experience or equivalent experience in related industry.- Competence in the selection and use of Quality Engineering Tools and Techniques.
- Ability to work independently and in team environment.- Ability to effectively communicate written and verbally.- Good knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g.
ISO, QSR, UL, CSA, VDE, etc.) - Certified Quality Engineering (CQE), Certified Software Quality Engineer (CSQE), Certified Reliability Engineer (CRE), Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), or Six Sigma Green Belt desired.What's In It for YouWe offer an above average and area competitive compensation plan and a complete and comprehensive benefits package.
Relocation assistance is available.This is a tremendous career opportunity to join a fast growing International Company located in the beautiful St. Louis, Missouri area.
- Applicants must be authorized to work in the U.S. CyberCoders, Inc is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.
Your Right to Work In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.
Location/Region: Saint Louis, MO (US)