Job Opportunities

Below is a listing of employment opportunities that may be of interest to our members.

Any organization or individual interested in posting a job opening on this page should email the details to Joey Yamanouchi at jyaman@acehardware.com before the first of the month. All listings will remain on the website for one month. Should a listing need to run longer, it must be resubmitted.

Please note: The ASQ-Illiana section does not recommend or guarantee any of the listed positions, but simply provides the information as a service to its members.


SENIOR QUALITY ENGINEER – Ohio and Florida


BASIC FUNCTIONS OF THE SENIOR QUALITY ENGINEER:
This position will oversee a diverse group of functional investigations that will be performed within the scope of the Quality department.

ESSENTIAL FUNCTIONS:

  • Conduct investigations into Medical Device Reports (MDR’s) with products with respect to applicable Federal regulations including 21 CFR 820, 803 and in accordance with ISO 13485 and internal Standard Operating Procedures
  • Assume lead role in investigating potential manufacturing / process issues with a goal of identifying potential root cause and assessing potential finished device impact
  • Investigation, monitoring, and follow up on CAPAs for completion and effectiveness
  • Author and approve investigation findings
  • Communicate with company personnel as to status of complaint investigation, recommended course of action, and the need for additional medical and/or supplementary information relevant to complaint investigations
  • Communicate with Quality departments as to the status of product analysis and the need for additional information relevant to the report
  • Able to participate in Risk Analysis activities including FMEA and PFMEA
  • Attention to detail and skill at auditing to ensure accuracy
  • Ability to work cross-functionally with various groups that have opportunity to impact the investigation outcome (Engineering, Operations, Quality, Commercial Operations, etc.)
  • Work closely with Quality Audit to assess current procedures/work instructions related to Quality and address deviations/findings
  • Monitor complaints received and provide trending and metrics as determined necessary for inclusion in management review
  • Review as needed Device History Records (DHRs) to verify calculations, product accountability, accuracy and proper GMP documentation practices and prepare them for final review and product release
  • Complete special projects as required in support of the location’s Quality function

REQUIREMENTS FOR THE POSITION:

  • Bachelors in Engineering or science related field
  • Experience working with heavy equipment and machinery
  • Five (5) years of process engineering, quality engineering, or investigatory experience in the medical device or FDA regulated field
  • Prior experience with root cause investigation tools and complaint file documentation
  • Knowledge of FDA (21CFR 803/806/820) and ISO (ISO:13485) regulations
  • Organized and details oriented; proven ability to meet deadlines
  • Strong analytical skills; verbal, and written communication skills
  • Ability to work individually and as part of teams
  • PC knowledge to include MS Word, Excel, PowerPoint, Access & Visio, and database management



    • Janet G. Shields
    Human Resources-Talent Acquisition
    jshields@invacarecontractor.com
    440.329.6942

    INVACARE CORPORATION
    One Invacare Way
    Elyria, OH 44035
    invacare.com