Quality Engineer

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

Millstone Medical Outsourcing is looking for an energetic individual to join its Quality Department as a Quality Engineer.  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.

The Quality Engineer is responsible for providing Prevention, Appraisal, and Failure tasks associated with ongoing process operations including contract review, inspection requirements planning, gauge & inspection tool design, metrology & calibration, validation & verification, inspection monitoring, process surveillance, material review, and continuous improvement studies.

The role of the Quality Engineer is to assist in the planning, executing, and finalizing projects to strict deadlines. Specific functional areas include the creation and maintenance of system procedures & work instructions, support the internal auditing program, as well as data analysis, complaint handling, and CAPA investigations. In addition to ensuring that customer and internal requirements are met while meeting the requirements of the company’s Quality Policy, established Quality Objectives, as well as regulatory requirements as outlined in ISO13485, FDA 21 CFR Part 820 & 1271.

KNOWLEDGE & SKILLS:

• Bachelor’s Degree with at least 5 years of Quality Engineering experience (associate degree with at least 10 years of experience).
• 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
• Knowledge and execution of issues related to FDA/GMP compliance
• CAD/CAM, Solidworks/Unigraphics or similar experience
• Ability to use standard measuring instruments, gauges, read and understand basic prints/drawings
• Advanced Math skills in algebra, trigonometry, & basic statistics concepts
• Capability to develop/design fixtures
• Advanced ability to create Microsoft Excel, PowerPoint & Word documents with expert ability to incorporate functions & write macros.  Microsoft Office certification a plus.
• 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
• Experience with statistical software (Minitab or equivalent)
• 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
• CQE certification highly preferred
• Lean Six Sigma a plus

PHYSICAL REQUIREMENTS:

Standing, stooping, light lifting (25 lbs. or less), manual dexterity, ability to read fine print, 20/20 vision or corrected 20/20 vision

ADDITIONAL INFORMATION:

Millstone Medical Outsourcing offers a competitive salary, health, dental and vision benefits beginning on the first day of employment and 401K with company match. Other benefits include paid vacation, paid sick time, holiday pay and voluntary benefits in addition to an employee-centric work environment. To learn more about Millstone Medical Outsourcing’s opportunities, visit us online at www.millstonemedical.com. If interested in this position, please apply now via Indeed.

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.

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