Easter Seals Jobs

Validation Quality Engineer (1925)

• Title:Validation Quality Engineer

• Group Company: Mitsubishi Chemical Advanced Materials

• Location:Fort Wayne, IN

• Employment Type:Full time

Group Company:

• Mitsubishi Chemical Advanced Materials

Mitsubishi Chemical Advanced Materials is a leading global manufacturer of high-performance thermoplastic materials in the form of semi-finished products and finished parts. The company has locations in 20 countries and more than 2,800 employees. Its specialty engineering thermoplastics and composites are superior in performance to metals and other materials and are used in a wide range of applications, primarily in the capital goods industry. The company is continuously developing new areas of applications in close cooperation with industry leaders in a broad variety of customer markets. The Mitsubishi Chemical Advanced Materials Group is well prepared to further expand its market leadership position.

Supporting the vision of our holding company, Mitsubishi Chemical Holdings Corporation (MCHC) (http://www.mitsubishichem-hd.co.jp/english/index.html) , Mitsubishi Chemical Advanced Materials is committed to the realization of KAITEKI, “a sustainable condition which is comfortable for people, society and the Earth”. To realize this vision, the MCHC Group engages in corporate activities that provide products, technologies and services based on the comprehensive capabilities of the Group in the Performance Products Domain, Industrial Materials Domain and Health Care Domain, with chemistry as the basis of our activities. We jointly express and promote our commitment under the corporate brand THE KAITEKI COMPANY.

Job Purpose

Technical leader and expert for MediTECH validations. This involves initiating, leading, coordinating, scheduling, and performing validations for MediTECH and MediTECH’s customers. Communicate with customers on expectations and create the validation documentation. Create an effective environment for validations that utilize the resources available.

Principal Accountabilities

• Initiate, lead, design, coordinate, and perform validations for MediTECH to fulfill internal, customer, regulatory and normative requirements and to continually improve the quality of MediTECH validations.

• Developing the validations protocols, designing the qualification trials, scheduling of verification and validation activities, performing the trials, statistical analyzing of the data and completing the validation summary reports

• Serve as an interface to the customer for validation and qualification efforts. Assist in the development of combined validation efforts and describe and explain MediTECH validation documentation to customers.

• Special project work for MediTECH. This could include new product and process launch, new equipment or software designation and installation, and training of personnel.

• Continually improve the knowledge of validation methods and techniques; train MediTECH employees on validations to improve the overall quality of MediTECH validation knowledge and performance.

• Creation of Risk Management support documentation including Process Flow Diagrams, PFMEA’s, Control Plans, etc.

• Support in general MediTECH Quality and Operations activities, such as participating in certification / customer audits, executing internal audits, carry out and support in quality control activities, participating in CAOA activities, the review of process and product deviations, and the review of process and product changes or additions (Including new item creation).

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Knowledge / Skills / Experience

• Bachelor's Degree required.

• Experience with validation methodology (IQ, OQ, PQ, Test Method Validation, etc.).

• Preferable experience with ISO 13485 Quality Management Systems.

• Preferable experience with ISO 14971 Risk Management

• Good understanding and knowledge of computer hardware and software. Professional skills in the sue of office software (such as MS Word, MS Excel, and Mintab).

• Preferable experience with statistical methods and analysis of data.

• Ability to use current resources to efficiently produce validation documentation.

• Professional communication skills. Business fluent in English.

Pay Transparency (complete highlighted sections)

• The salary range for this position is $80,010 - $120,015. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills, internal peer equity, as well as market and business considerations may influence base pay offered. This salary will be subject to a geographic adjustment (according to a specific city and state), if an authorization is granted to work outside of the location listed in this posting.

• Competitive Benefits

• Benefits begin on DAY 1!

• Employee Assistance Programs

• Curated Self-Paced Learning & Development Programs for all Employees

• Sign-On Bonus of $5,000

Mitsubishi Chemical Group (MCGC) and any of our subsidiaries do not accept unsolicited resumes from individual recruiters or third-party agencies. No fee will be paid to third parties who submit unsolicited candidates directly to our hiring managers or HR team. No placement fees will be paid to any firm unless specifically invited on the search by the MCGC Talent Acquisition team and such candidate was submitted to the MCGC Talent Acquisition Team via our Applicant Tracking System.

EEO Statement

Mitsubishi Chemical Corporation values diversity in the workplace, is committed to a policy of equal employment opportunity and will not discriminate against an applicant or employee on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or any other legally recognized protected basis under applicable law.

Applicants with disabilities may be entitled to a reasonable accommodation under the Americans with Disabilities Act and/or other applicable laws. If you require accommodation due to a disability at any time during the recruitment and/or assessment process, please contact Talent Acquisition.