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Quality Assurance Director

Company: Oasis
Location: Glendora
Posted on: November 22, 2021

Job Description:

Job Summary

The Quality Assurance (QA) Leader - plans and directs - all aspects of the Company's product quality an d continuous improvement programs - for its ophthalmic surgical supplies and vision care products by implementing and maintaining vendor standards and process controls, conducting inspection activities, performing analysis and measurement of results , and monitoring customer feedback and complaints . - Oversees - regulatory requirements, including maintenance and compliance with FDA Quality System and Medical Device Directive , as well as ISO certification. - S upervises team of Quality Assurance Engineers, Technicians and Coordinators . - The position performs a vital part in enhancing the Company 's infrastructure, and has the capability to contribute to the strength and sustainable growth of Oasis Medical.

Essential Job Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Manage daily activities of Quality Assurance staff with respect to attendance, job performance, work assignments and priorities;
Coordinate, facilitate, and conduct investigations with respect to material, product and process non-conformances and identify corrective and preventive actions;
Interact with external suppliers in regards to product requirements, nonconforming material/products and required corrective and preventive actions;
Manage the c omplaint system (review, evaluate and investigate all customer complaints, identify trends);
Write and/or implement changes to controlled documents as needed;
Participate in providing relevant product/process data information and/or summary to various departments to support internal product operations;
Compile data for annual product review reports, evaluate all data, perform trend analysis and prepare summaries highlighting problems and areas for improvement;
P rovide timely QA-related information as requested for the purpose of regulatory agency audits;
Participate in the development of protocols and validation reports on proposed new equipment, materials and processes;
Participate in internal and external Quality Audits as needed;
Evaluate vendors, and m aintain a Qualified Vendor system;
Perform and document training for new products, processes and associates as needed;
Oversee activities in order to maintain an effective Document Control System;
Oversee activities in order to maintain an effective Equipment Calibration system;
Prepare and present associate performance appraisals;
Identify change and improvement in work processes to promote efficiency as OASIS grows
Adhere to general safety rules, manufacturing procedures, and quality procedures as applicable
Exhibit professional behavior and demeanor at all times; proactively resolve issues using Best Practices
Perform other duties and responsibilities as requested or assigned
Comply with all Company policies

Experience/Training/Education

Bachelor's degree in Business , Industrial Technology, or a re lated technical field
Minimum 10 years knowledge and experience in Quality Assurance;
Ten (10 ) years' experience in supervision of Quality Assurance inspection activities;
Experience with sterile products and microbiology, including validation activities;
Proven ability to maintain ongoing compliance in an environment regulated by Quality System Regulations a nd the Medical Device Directive

Knowledge/Skills/Abilities
General: - Demonstrate s trong time management and organizational skills. - Ability to prioritize multiple tasks and meet deadlines. - Attention to detail. - Ability to work well individually and as a team member and demonstrate a flexible and collaborative approach when working with cross-functional teams. - Takes the initiative to identify and implement ef fective solutions. - Demonstrate professionalism by leading with integrity, accountability and transparency. - Must demonstrate sound work ethic, flexibility, respectfulness, honesty and trustworthiness. - Must also be punctual and dependable. Must possess cultural awareness and sensitivity.

Technical: - Knowledge and/or experience in industry that is regulated by the Quality System Regulation and the Medical Device Directive. - Understand and apply FDA Quality System and ISO regulations. Knowledge and/or experience with inspection equipment and techniques; statistical sampling and process control charts. - - Knowledge and/or experience with batch production record review; sterilization; biological testing and related standards. - Knowledge and/or experience in internal and external quality audits.
Able to organize effectively and maintain detailed quality records/documentation . - Demonstrate proficiency in Quality Assurance/Quality Control inspection equipment and techniques; statistical techniques, statistical sampling plans. - Develop and establish product and quality system procedures;

Communication: - Strong written and verbal communication skills. A bility to effectively present information in one-on-one and small group situations. - Ability to write reports, business correspondence, and procedure manuals . - Ability to respond to common inquirie s or complaints from customers or regulatory agencies. - Ability to communicate diplomatically and respectfully.

Math & Reasoning: - Ability to read, analyze and interpret common scientific and technical journals, Possess excellent problem solving techniques , i ncluding a bility to define problems, colle ct data, establish facts, and draw valid conclusions. - Ability to interpret an extensive variety of technical instruction in mathematical or diagram form and deal with several abstract and concrete variables. - Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

Keywords: Oasis, Glendora , Quality Assurance Director, Executive , Glendora, California

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