Quality Engineer I
Quality Engineer I
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1 Vacancy
Job Description
Founded in 1990 and based in New Richmond WI Isometrics vision was to manufacture tooling and provide manufacturing solutions to exacting specifications for ultrasmall ultraprecise and ultracomplex applications. For the past 35years were proud to say weve grown to be one of the largest medicalfocused micro molders in the United States. In March 2024 Isometric was acquired by Nissha Medical Technologies (NMT) a global Contract Design/Development Manufacturing Organization. NMTs expertise in the design and development of endoscopic devices combined with Isometrics market leading micromolding capabilities are revolutionizing drug delivery and medical devices including minimally invasive surgical instruments and surgical robotics. Together we aim to meet the evolving needs of medical devices enhance component miniaturization and improve the maneuverability of small and precision components ultimately contributing to improved device functionality.
Its an exciting time to join our team and were hiring for aQuality Engineer I. This position contributes to project performance verification of product/process conformance and customer satisfaction by providing technical expertise and leadership in executing product assurance engineering activities throughout the project development lifecycle. This role also supports quality improvement activities and helps implement and maintain items within the Quality Management System (QMS).This is an exempt paid position and thehours for this position are MondayFriday 7:00AM3:30PM.
Essential Functions and Responsibilities:
- Draft and document quality procedures instructions inspection methods control plans and other productrelated documentation.
- Work with suppliers of both raw materials and components to improve product quality and/or resolve quality issues as needed.
- Participate in internal and external audits.
- Support customer audits.
- Work with customers to understand and align all quality requirements.
- Assist Material Review Board (MRB) to ensure timely disposition of products while ensuring corrective and preventative actions meet regulatory requirements.
- Support continuous improvement initiatives.
- Manage and investigate customer complaints including Device History Record (DHR) reviews.
- Other duties as assigned.
Education and/or Experience:
- Bachelors degree or equivalent education/experience required.
- Minimum of 3 years of experience in the Medical Device Industry.
- Familiarity with Quality Systems and regulatory agencies preferably ISO 13485 and FDA 21 CFR 820
- Familiar with standard concepts practices and procedures within quality inspection.
- Computer proficiency in MS Word and ERP systems preferred
- Knowledge of clean room practices preferred
Isometric offers a comprehensive benefit package along with competitive pay:
- 401(k) program with Company match available after 90 days
- 3 weeks of paid time off 2 personal days and 11 paid holidays 10 observed holidays 1 floating holiday of your choice)
- Medical Dental and Vision options available the 1st of the month followed by your hire date. Health Savings Account options available including a quarterly company contribution
- Company paid coverages include Employee Life/AD&D & ShortTerm Disability
- Voluntary benefit options include LongTerm Disability Supplemental Life/AD&D for Employees Spouse and Children Group Accident InsuranceHome Warranty coverage Legal support coverage and Pet insurance!
- Hands on training
Isometric a NMT Company is an Equal Opportunity employer. We are committed to creating a diverse workforce; we support a work environment where colleagues are respected and given the opportunity to perform to their fullest potential. We consider all qualified applicants without regard to race religion color sex national origin age sexual orientation gender identity disability or veteran status among other factors.
Employment Type
Full Time
