Quality Engineer


Quality Engineer supporting IQC, Calibration, Manufacturing, Document Control, NCRs/CAPAs, Supplier Management, Complaints, Internal Audits, Risk Management, Protocol and Report development and approval, quality data analysis and works closely with Manufacturing, R&D, and Quality Engineering groups.  Technical contributor who can help define quality metrics and specifications, identify key opportunities for improvement, launch quality initiatives, and help solve technically challenging quality problems.

Major Duties & responsibilities

  • Responsible for supporting QA, Manufacturing, and R&D

  • Facilitate and perform component/material qualifications

  • Assist in the development of dFMEAs (Design Failure Mode Effect Analysis) and pFMEAs (Process Failure Mode Effect Analysis) and control plans where required

  • Facilitate validations and component acceptance activities

  • Identify when gage R & R studies are needed

  • Drive continuous improvement in production and supplier performance

  • Optimize process capability on significant characteristics through effective application of statistical analysis techniques and training in problem-solving

  • Utilize analytical skill sets to implement root-cause analysis and provide recommendations for corrective action

  • Drive corrective actions to verify component and process quality

  • Trending of quality metrics

  • Manage databases and files. Maintain accessible records for internal and third-party audits

  • Support Product Development and ensure that the essential performance aspects are mitigated in product quality plans

  • Identify critical elements of designs. Recommend design processes and methods to meet quality goals

  • Plan and create quality standards and procedures, sampling plans, test methods, fixtures, and processes

  • Provide guidance to other engineers regarding applicable regulatory and statutory requirements and the applicability of these requirements to the products

  • Stay current with FDA and International requirements and industry trends in regards to regulations and expectations for industry


Education & Experience

  • A 4-year degree in engineering, scientific discipline, or similar.

  • 2 years engineering experience supporting a medical device or related environment (Preferred)

  • Experience in document control, equipment management, and supplier management (Preferred)

Other Requirements

  • Knowledge of national and international regulations applicable to medical devices including; 21 CFR 820 (Quality System Regulations), ISO 13485, and MDD 93/42/EE

  • Ability to interact effectively (both verbal and written) with associates across all departments within an organization at all levels

  • Must have strong proofreading skills and organizational skills, as well as exemplary attention to detail

  • Must have demonstrated initiative and ability to work independently and under supervision of senior-level employees while handling multiple tasks

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand, walk and sit and work at a computer for extended periods of time. Occasionally the employee will be required to lift or move at least 25 pounds.



Interested candidates should submit their resume to careers@shapemem.com with the job title as the subject.

Resumes from recruiters will not be accepted.