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 Mechanical Inspection Operations Manager is responsible for monitoring and assigning inspector's day-to-day activities to meet client and Millstone needs. Acts as the Quality liaison with external clients for projects. Identifies and addresses process gaps as well as assisting the inspectors with problem resolution. Works closely with departmental managers to ensure staff are working in compliance with internal policies and procedures, external client expectations and GMPs. This position includes visual inspection of medical devices and instruments which requires the ability to detect defects. 20/20 or corrected 20/20 vision is required.
Knowledge & Skills
• Ability to use and train others to use scales/gauges/calipers/Tappi and color charts
• Ability to use, program, maintain and train others to use dial indicators, comparator and CMM
• Ability to read and understand basic prints/drawings
• Ability to develop/design fixtures
• Ability to calibrate with workmanship expectations of customer
• Ability to recognize and communicate potential issues
• Advanced Math skills in algebra, trigonometry, & basic statistics concepts
• 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
• Excellent reading, verbal, and written communication skills. English is required.
• Ability to review procedures for correctness, write or re-write procedures and check sheets
• Independent worker with great leadership and organizational skills, with the ability to prioritize and set the pace for others
• Understands workflow or daily requirements
• Knowledge and execution of issues related to FDA/GMP compliance/understanding of GD&T
• Requires 5-7 years of prior Medical Device QA experience, 2-4 years prior Medical Device QA/Supervisor experience, 2-4 years prior management experience
To learn more aboutMillstone Medical, please visit us online at www.millstonemedical.com.
ADDITIONAL INFORMATION:
Millstone Medical Outsourcing provides equal employment opportunity to all applicants andemployees. No person is to be discriminated against in any aspect of the employment relationshipdue to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, genderidentity, 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.