Coagusense Inc. Looking for Quality Engineer at Fremont, CA Full Time

SUMMARY

The Quality Engineer (QE) works closely with cross-functional teams including R&D, Procurement, and Manufacturing to identify and mitigate quality risks. Performs product, process, and change control risk mitigation actions by auditing production processes, raw materials or suppliers/vendors to ensure that established quality standards are met. Conducts root cause analysis for returned goods, product defects, non-conformities or other quality failures.

Externally, this position will also work with the meter OEM to provide continuous feedback and coordinate more complex repairs, analysis, etc.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Responsible for driving continual process improvements in responsible areas of the business. Drive quality and manufacturing improvements to assure that processes are in a state of control. Develop and maintain effective relationships and integrate activities with other departments and suppliers as applicable.
• Review and approve changes made to product and processes and validation/qualification protocols and reports. Proactively work closely with manufacturing engineering for new validation or revalidation activities.
• Process returned goods per internal procedures, providing an analysis and investigation of returns, repairing of units if warranted, and preparing units as replacements. Confirm customer complaints, identify root causes, and thoroughly document actions taken in associated databases, forms, etc. Work closely with Technical Support and Quality Assurance for timely processing of customer complaints and associated feedback for continuous improvements. Maintain required hardware for repairs and assure all relevant SW used for analysis is current and updated as required.
• Provide trend analysis and metrics regarding returned goods, raw material acceptance, supplier performance, and other associated activities, contributing to semi-annual management review meetings.
• Work with internal customers and suppliers to ensure that process validation related non-conformances, failure analysis reports and deviations are appropriately investigated, documented, reviewed and approved.
• Provide QA support to product Distribution Centers when required.
• Initiate, develop and/or revise standards and methods for inspection, testing, and evaluation, as necessary. Assure product compliance to specifications through implementation of inspection criteria, procedures and training.
• Manage company’s equipment list and calibration program to ensure accuracy and compliance with all applicable requirements. Maintain database, hard copy files and control backup portable equipment.
• Other duties may be assigned within the function of Quality Assurance as needed and deemed appropriate.

QUALIFICATIONS

• Bachelor’s degree in engineering or other technical discipline, or advanced degree (MS or PhD) in other disciplines, or equivalent experience will be considered.
• Minimum of 7 years of quality engineering or equivalent experience in FDA regulated medical device or IVD manufacturing environment(s). Hi-tech industry experience will be considered.
• Requires a working understanding and knowledge of both U.S. and international regulations, including FDA Quality System Regulations (21 CFR Part 820) and ISO 13485 Medical devices — Quality Management Systems, and all relevant domestic and international standards as outlined in the company’s Quality Manual.
• Experience working with medical devices with software controls and good understanding of software development life cycle desired.
• Proficiency in reading and interpreting mechanical drawings and specifications. Experience with diagnostic testing equipment for electromechanical medical devices.
• Strong language skills to analyze and interpret technical information, write reports and procedures, and effectively present information to managers and/or employees. Possess a strong ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to work with mathematical concepts, such as general statistical techniques. Experience with Excel highly desirable for tracking and trending needs.
• Strong documentation skills following quality requirements and Good Documentation Practices.
• Demonstrated ability to perform detail oriented work with a high degree of accuracy and recall. Requires strong written, oral, interpersonal, group, and communication skills. Effective organization and planning skills.
• Must be able to follow established policies and procedures, revise or create new procedures, and comply with regulatory requirements.
• Computer skills are required, with experience using Microsoft Word, Excel, and PowerPoint.
• Demonstrated ability to deal with unresolved situations, frequent changes, delays or unexpected events.
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above and below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

• Bachelor’s degree in engineering or other technical discipline, or equivalent required. Advanced degree (MS or PhD) a plus.
• Must have a working understanding of quality principles and experience working under a Quality Management System.

LANGUAGE SKILLS

• The ability to communicate articulately, in English, both verbally and in written materials is required.

REASONING ABILITY

• Ability to recognize problems, recommend and implement solutions. A logical and organized thought pattern is required.