Quality Engineer I (Medical Device)

Full Time
Olive Branch, MS 38654
Posted
Job description

Come join Millstone Medical and become part of a high growth company where you will have the opportunity to learn and grow in an employee-centric culture and see the importance of your work!

Millstone is a fast growing, fast paced medical service provider for the top Orthopedic companies in the industry. Millstone’s business focus is sterile and non-sterile packaging of medical devices.

Millstone also engages in other activities, such as mechanical inspection and assembly, which are designed to meet the outsourcing requirements of medical device manufacturers seeking to reduce costs while maintaining high levels of quality, accuracy, and timeliness. We are FDA and ISO registered and employ a detailed internal quality system to ensure ISO compliance.

What's in it for you?

A company committed to quality, growth, career pathing.

At Millstone, we want you to be your best at work and at home. In addition to competitive compensation, we have designed our Total Rewards Benefits Program to support the physical and emotional well-being of our employees and their families.

Total Rewards Benefits Program:

  • Medical - Starting on the 1st day of employment
  • Dental - Starting on the 1st day of employment
  • Vision - Starting on the 1st day of employment
  • Supplemental Benefits - Life, Disability, Critical Illness
  • Paid Time Off
  • Tuition Reimbursement
  • Career Pathing
  • 401(k) with match

The Quality Engineer will be responsible for providing Prevention, Appraisal, and Failure tasks associated with ongoing process operations including:

    • Drawing/specification review
    • Inspection requirements planning
    • Calibration system oversight
    • Validation & verification
    • Inspection monitoring
    • Process surveillance
    • Internal audit
    • Data analysis
    • Corrective & preventive action investigation & reporting
    • Complaint investigation and improvement studies
  • Assist in the creation and maintenance of system procedures & work instructions as well as prepare Inspection Reports for use in operations
  • Works seamlessly with customers and calibrate with workmanship expectations
  • Consistently above average when it comes to productivity/efficiencies, sets the pace for others
  • All other duties as assigned

KNOWLEDGE & SKILLS:

  • Bachelor’s Degree with at least 2 years of Quality Engineering experience (associate degree with at least 5 years of experience may be considered).
  • Advanced inspection and mechanical aptitude
  • Excellent verbal and written English communication skills
  • High attention to detail and the ability to work in a team environment are essential
  • Understanding of GD&T a plus
  • Knowledge and execution of issues related to ISO 13485 and FDA/GMP compliance
  • Ability to use standard measuring instruments, gauges, read and understand basic prints/drawings
  • Advanced Math skills in algebra, & basic statistics concepts
  • Advanced ability to create Microsoft Excel, PowerPoint & Word documents with expert ability to incorporate functions & write macros.
  • Excellent interpersonal and customer service skills
  • Easily able to recognize & communicate potential issues
  • Ability to follow and review department procedures for correctness and write/re-write procedures when necessary
  • Excellent interpersonal and customer service skills
  • Works well with internal customers from various levels of the organization
  • Capacity to train others, including “training the trainer”
  • Works independently and easily resolves minor daily issues/problems
  • ASQ CQE certification highly preferred
  • Six Sigma training a plus

To learn more about Millstone Medical, please visit us online at www.millstonemedical.com.

ADDITIONAL INFORMATION:

Millstone Medical Outsourcing provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status or any other status protected by applicable federal, state, or local law.

All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.

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