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  • Home
  • Who We Are
    • Who We Are
    • Plastikos Medical
    • Plastikos
    • Micro Mold
    • Leadership Team
  • What We Do
    • What We Do
    • Product Enhancement
    • Precision Mold Manufacturing
    • Medical Injection Molding
    • Advanced Plastic Processing
    • Value Added Operations
  • Our Market Focus
    • Our Market Focus
    • Medication Delivery Systems
    • Surgical Devices
    • Respiratory
    • Digestive Health
    • Bio-Processing
    • Electronic Connectors
  • Why Us
    • Why Us
    • Engineering Horsepower
    • Industry Recognition
    • Risk Mitigation
    • Education and community outreach
    • Environmental Stewardship
  • Get In Touch
    • Explore Erie
    • Join Our team
    • Literature and Certifications
  • News
  • 0

Quality Engineer

JOB SUMMARY:

To manage quality product inspection documentation activities and quality product issues as assigned. Obtain, review, and control product prints, inspection plans, first article inspections, PPAP, IQ / OQ/ PQ, or other documentation related to ongoing and new qualification activities.

ESSENTIAL POSITION FUNCTIONS:

  1. The primary or essential functions of the position are listed below. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  2. Print reviews to ensure compliance with customer requirements, and communicate with customers, if Plastikos cannot meet print requirements as written
  3. Manage the following IQMS and Total Lean Management modules, as it pertains to the quality function: ECO, Document Control, SPC, Inspection, and other pertinent quality system modules
  4. Work with Tooling Engineers to help resolve potential tooling problems that affect the quality of our customer’s product
  5. Manage first article and PPAP activities, as required by the customer or internal needs
  6. Manage qualification activities and reporting for customers in conjunction with other engineering teams
  7. Coordinate outside calibration services for inspection equipment
  8. Help with product disposition as it relates to product nonconformity, and communicate with customers on deviation request(s), if required
  9. Investigate customer concern notifications and corrective actions as designated by the Quality Manager and/or Manufacturing Manager
  10. Create inspection plans and supplemental inspection documentation, as required
  11. Update quality documentation, as required
  12. Conduct statistical analysis, as required
  13. Identify continuous improvement opportunities in the quality department such as streamlining information, new inspection methods, increased inspector knowledge, etc.
  14. Other duties as assigned by the Quality Manager

MINIMUM JOB QUALIFICATIONS & SKILLS:

  • Bachelor’s degree in an Engineering Discipline
  • ASQ Certification, preferred
  • Clearly and effectively communicates in English (verbal and written)
  • Communicates effectively with teammates
  • Works well independently (self-motivated), as well as in a team environment
  • Makes good decisions when problem solving, and independent judgment are required
  • Maintains a positive attitude and strong individual work ethic
  • Possesses a strong attention to detail
  • Is capable of multi-tasking
  • Consistently meets deadlines
  • Excellent statistical skills
  • Proficient computer skills (Microsoft Office, Windows, IQMS, TLM, MiniTab)
  • Excellent print reading skills with GD&T knowledge
  • Experience with various measurement systems (OGP, CMM, CT)
  • Ability to plan independently
  • Capable of completing job duties in a highly professional and confidential manner
  • Regards safety as a priority
  • Possesses a commitment to housekeeping and to maintain clean work environment
  • Is willing to work outside of regular hours, if required

Employees must exemplify the company’s core values of customer service, teamwork, professionalism, respect, and continuous improvement.

WORK ENVIRONMENT:

  • Climate controlled manufacturing/production work environment
  • ISO 9001 controlled quality and production processes
  • ISO 7 (Class 10,000) Cleanroom environment (additional training required)

Apply Today

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