MAIN JOB RESPONSIBILITIES / COMPETENCIES
1.    Primary responsibility is to manage the EWOK software administration module which includes:
a.    Setting up all new devices in EWOK including device location; status; mode and its associated printers.
b.    Updating equipment status in EWOK so that only validated and active equipment is available for use.
c.    Adding users and setting their security levels based on the user’s role. Also, providing users with a barcode and initial password.
d.    Initiating changes or adding new routers as required based on work definitions after getting the changes approved through eQMS.
e.    Revising Router Step Master; Process Codes; Material List Master; Reject Codes based on changes to the manufacturing process or packaging components.
2.    Working with the Quality Control team to create or modify the QC checklists.
3.    Notifying collaborators and approvers on proposed changes to the approved processes and update the appropriate EWOK administration tab sub-contents.
4.    Collaborating with manufacturing supervisors and maintenance department in setting up or replacing devices and their components at all required locations – this includes tablets or laptops or PCs (set to the latest EWOK version), scanners, power source, and articulating arms or stands.
5.    Conducting hands-on training in using EWOK at all manufacturing steps for all production personnel and QC. This includes EWOK transactions at all workstations, completing job pull sheets, tumbling and hydration logs, sterilization logs, and QC checklists.
6.    Providing day-to-day trouble shooting and support with access, scanners, tablets and all other EWOK related tools and processes. 
7.    Identifying, recommending and implementing process improvements to enhance EWOK capability.
8.    Executing pre-validation testing and software verification and validation protocols as directed by the quality engineering group.
9.    Other duties as assigned.

REQUIREMENTS

EDUCATION & TRAINING
•    Must possess a high school diploma/general education diploma (GED) or equivalent combination of education/experience.

EXPERIENCE
•    Minimum 2 years’ experience in medical device manufacturing.
•    Familiarity with the quality control system in a Good Manufacturing Practices (GMP) environment is required.
•    Experience with using various off the shelf software (eQMS and MES) is preferred.
•    Flexibility on schedule is preferred.

SKILLS
•    Must be able to read, write and speak English fluently.
•    Attention to detail and accuracy.
•    Ability to take direction from lead/supervisor and other management and contribute to departmental goals.
•    Good interpersonal and written communication skills.
•    Intermediate software skills including Word and Excel strongly preferred.
•    Ability to learn quickly and work independently.

Pay range is $24-$32/hr  - Final compensation will depend on experience.

STAAR Surgical is an Equal Employment Opportunity/Affirmative Action employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status, or any other characteristic protected by law.