• Senior Quality Engineer

    Job Locations US-MA-Beverly
    Job ID
    2018-1245
    # of Openings
    1
    Category
    Engineering
  • Overview

    We love automation. We design and build innovative robotic systems and laboratory devices used by pharmaceutical and biotech companies and academic research laboratories. HighRes Biosolutions helps scientists accelerate drug discovery, high throughput genotyping, siRNA screening, next-generation sequencing sample prep, biorepository science and molecular diagnostics with highly flexible, expandable and modular integrated systems, bench-top devices and consumables that are easily configured (and reconfigured) to create research environments conducive to achieving breakthrough results.

    Responsibilities

    Highres Biosolutions is seeking a Senior Quality Engineer with expertise in managing and improving product quality and experience in implementing and improving quality management systems. You will represent the voice of the customer and drive continuous improvement throughout the organization. You will work among a talented cross functional team bringing novel robotics, instruments and lab automation systems for the life science industry to market.

    • Implementation and management of system for measuring and improving product quality including development of corrective action plans to drive improvements to product design, manufacturing process and field service
    • Design of effective quality and process control plans to ensure product shipments meet performance and quality requirements
    • Implementation and management of CAPA system
    • Management of field returns and complaints
    • Provide regular product quality and performance updates
    • Recommend and develop business process tools to improve and enhance the quality function
    • Customer interface managing quality escalations and audits
    • Support implementation and management of quality management system

    Qualifications

    • Bachelor’s degree in engineering with 4+ years of experience in a quality role working with complex electro-mechanical systems and capital equipment with software
    • Experience using and maintaining system to measure and improve product quality
    • Highly skilled with SPC, root cause analysis and tools and other problem-solving methodologies
    • Experience with DFMEA/PFMEA and DOE
    • Experience setting up product quality databases
    • Experience participating in regulatory, third party and customer audits
    • Proficient with MSOffice and minitab. Weibull++ is a bonus
    • Experience with implementing and maintaining quality management systems
    • Experience writing and managing standard operating procedures and other quality related procedures and policies
    • Excel in a fast paced, dynamic environment as part of a multi-disciplinary team
    • Experience working with stage gate product development process
    • Strong planning, organizational and interpersonal skills
    • Must be self-motivated with ability to multi-task
    • Ability to travel up 10% domestically and internationally

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