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| Job Category : | Engineer |
| Company Name: | Millstone Medical Outsourcing |
| Position Name: | Quality Engineer |
| Location : | 580 Commerce Drive, Fall River, MA 02720 |
| 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 employmentDental – Starting on the 1st day of employmentVision – Starting on the 1st day of employmentSupplemental Benefits – Life, Disability, Critical IllnessPaid Time OffTuition ReimbursementCareer Pathing401(k) with matchTo learn more about Millstone Medical Outsourcing, please visit us online at www.millstonemedical.com.**Visa sponsorship and relocation is not available for this position.**RESPONSIBILITIES: Lead and manage engineering and operations projects per agreed upon timelines that include equipment, software, product & process validations.Lead corrective action teams, sometime across multiple sites, as part of Millstone’s CAPA system to investigate, determine root cause, develop and implement corrective actions.Lead change control efforts through Millstone’s change control process as necessaryDevelop and provide oversight to gage R & R’s and serve as primary point of contact for documentation associated with out of tolerance equipment.Identify and lead preventive action projects that reduce non-conformances and improve operational efficienciesComplete statistical analysis and provide metrics internally as well as to clients (management review, CQR, KPI, etc.) as required.Serve as the primary Quality contact for selected client groups, which includes review of validations, document changes, process changes, and client issued SCARs.Participate in internal and external audits as needed.KNOWLEDGE & SKILLS REQUIRED: Bachelor’s degree in Engineering required2-5 years relevant Quality experience. ISO 13485 and FDA environment experience is requiredMust possess excellent verbal and written communication skills, English is requiredCustomer service & interpersonal skillsA keen eye for detail is criticalAbility to work in a team environment is essentialAbility to multitask and complete work independently is crucialExcellent problem solving and decision-making skills are vitalADDITIONAL 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.Job Type: Full-timeBenefits:401(k)401(k) matchingDental insuranceEmployee assistance programHealth insuranceLife insuranceTuition reimbursementVision insuranceSchedule:8 hour shiftMonday to FridayWork Location: One location |
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