Job Title: Quality Engineer
Reports To: Manufacturing Quality Control Manager
FLSA Status: Exempt
Department: QC/QA


Summary: Responsible for supporting non-conforming product, failure investigations, environmental monitoring assessment and tracking, corrective and preventive actions, complaint handling, technical & manufacturing engineering support for all Quality Assurance functions associated with the products of this company.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Responsible for non- conforming product, tracking, and maintaining the access data base. Work closely with manufacturing engineers and R&D Engineers in the investigation of non-conformances to determine the root cause and recommend appropriate corrective and preventive action to prevent recurrence.
• Ensures assigned supplier CAPA’s are addressed and closed in a timely manner.
• Responsible of Deviation Data System.
• Support the Environmental monitoring of the cleanroom and other environmentally clean areas, scheduling, review and tracking of data. Recommend corrective actions needed when excursion from the alerts and action limits arise.
• Responsible for product release by reviewing the device history records.
• Maintain up-to-date the incoming quality control documents into Omnify.
• Assist in failure investigation, testing prototypes and new products, as well as product verification testing.
• Responsible to review and approve the Service Records as QA representative.
• Ensures adequate product test plans are developed and executed in accordance to internal and external design requirements (21CFR820, ISO13485, applicable ISO standards, IEC, UL, ANSI, and other applicable standards).
• Ensures all equipment and tooling used to Disposables / Instruments manufacture assemble or test product or components has been validated. Construct new products Design History File. Assist in the preparation for Regulatory filing documents, such as pre-IDE submissions, IDE submission, and other documents as necessary.
• Perform any other duties assigned by management.

Knowledge, Skill and Competency Requirements:
To perform the job successfully, an individual should demonstrate the following knowledge, skills and competencies:

• At least six years related experience with Manufacturing Operations and Quality Systems in a regulated environment, preferable medical devices industry.
• Working knowledge of QSR, ISO, EN standards, Good Clinical Practice, Clinical standards and Regulations.
• Communication Skills – Strong written, oral, interpersonal, team and telephone communication skills.
• Analytical – Collects and researches data prior to making decisions. Displays willingness to make decisions; Exhibits sound and accurate judgment.
• Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations.
• Strong computer skills are needed, with experience using Microsoft Word, Excel and Outlook.
• Knowledge of FDA Good Manufacturing Practices and Good Laboratory Practices, ISO13485

Education/Experience:
BS in Science or related scientific field and familiarity with the medical device business

Supervisory Responsibilities:
This job has no supervisory responsibilities.

Required Training:

The area supervisor or department head (or delegate) shall determine what internal training (if any) is required in order to satisfactorily meet the job requirements listed above. Such training shall be conducted in accordance with applicable SOPs and said training shall be documented in accordance to our internal training procedure. The employee shall also receive general training in both 21CFR 820 and ISO13485 as well as the OptiScan Quality Manual and Quality Policy.

This job description does not state nor imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job related duties as requested by management and will also be required to meet safety-related requirements. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.

If you are interested in applying to an open position at OptiScan, please email your resume to [email protected]