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Quality Engineer

Harmonic Drive LLC

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Posted on 09/03/2021

Location

Beverly, MA

Description

Summary/Objective

The primary responsibilities include assisting in examination and approval of components and finished products, equipment, processes and related documentation. Utilizing different tools and techniques, the Quality Engineer will help ensure that only the highest quality products are delivered to our customers.

Major Duties & Responsibilities

Essential Functions

  • Conducts and supports investigations of manufacturing nonconformities; recommends, develops and implements effective corrective actions.
  • Coordinates, collects, analyzes and distributes quality monthly and quarterly metrics.
  • Uses analytical methods to assess product and process performance and quantify the effect of changes.
  • Participates in audits conducted by regulatory agencies and/or customers.
  • Conducts internal audits of processes and outcomes.
  • Participates in supplier evaluation and selection assessments.
  • Participates in risk assessment and risk management activities including FMEA and development of control plans.
  • Ensures appropriate compliance and operational effectiveness in all areas of the QMS including document control, change control, training, complaint handling, CAPA, nonconforming process and auditing (internal and external).
  • Works in collaboration with Product Development to ensure that the designs, procedures and outcomes of the project are acceptable in quality.
  • Proficient with Microsoft Word, Excel & PowerPoint.
  • Proficiency with Minitab, JMP or other statistical software suites is a plus.

Minimum Skills & Abilities

Competencies

  • Experience with ISO 13485 and ISO 9001 certification and FDA’s 21CFR 820 preferred.
  • Demonstrated experience with mechanical measurements and understanding of GD&T required.
  • Experience in a Good Manufacturing Practice (GMP) environment is required.
  • Extensive experience writing and implementing policies, processes and procedures is required.
  • ASQ certified Quality Auditor and/or Quality Engineer is preferred but not required.
  • CQE, CRE, PE, CRA Certifications are highly desirable.
  • Lean Six Sigma Green or Black Belt required.
  • Experience with statistical methods including measurement system analyses, process capability analyses, regression analyses, tests for equal means and variances and design of experiments.
  • LIMS and ISO 17025 experience is a plus.
  • Excellent written and oral communication skills.

Minimum Education & Experience

Required Education and Experience

  • Minimum of 5 years of overall QA experience in an ISO (FDA is a plus) regulated environment, with at least 3 years in a direct Quality role is required.
  • College degree is preferred but not required (5 years with degree/10 years without).

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Harmonic Drive, LLC engineers and manufactures precision servo actuators, gearheads and gear component sets. We work closely with Fortune 500, start-ups and companies of all sizes to understand their application requirements and provide a standard or, in most cases, a custom-engineered solution to enable the success of their design project. Since the beginning, our engineering and production teams have continued to develop enabling technologies and products for the evolving motion control market. For over 50 years, Harmonic Drive has been you’re your partner for precision motion control. Today, high precision Harmonic Drive® strain wave gears continue to be engineered and manufactured by Harmonic Drive LLC in the US, Harmonic Drive SE in Germany and Harmonic Drive Systems, Inc. in Japan. With shared values, designs and quality standards, we locally serve the needs of our global customers. Harmonic Drive is a registered trademark of Harmonic Drive Systems. ISO9001 & AS9100 registered.

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