Quality Assurance Director
OASIS Medical Inc.
OASIS Medical Inc.
Glendora, CA Glendora, CA Full-time Full-time $120,000 - $150,000 a year $120,000 - $150,000 a year Company Information:
OASIS is a continuous improvement company with an unwavering commitment to truth and accountability.
We believe in strategic partnerships, creating a quality eye care experience with solution-based products that result in long-term sustainability.
We are committed to a win-win approach to all that work with OASIS.
Our professionalism is demonstrated by our ability to think different.
Job
Summary:
The Quality Assurance (QA) Director plans and directs all aspects of the Company's product quality and 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.
Supervises team of Quality Assurance professionals including 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:
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 complaint 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; Provide 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 maintain 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 related technical field required; Minimum 10 years knowledge and experience in Quality Assurance; Ten (10) years' experience in supervision of Quality Assurance inspection activities; Minimum 5-7 years of QA Managerial level experience; Experience with sterile products and microbiology, including validation activities; Proven ability to maintain ongoing compliance in an environment regulated by Quality System Regulations and the Medical Device Directive.
Knowledge/Skills/Abilities:
General:
Demonstrate strong 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 effective 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; OASIS Medical is an Equal Opportunity Employer.
No third party responses please.
Job Type:
Full-time Pay:
$120,000.
00 - $150,000.
00 per year
Benefits:
401(k) 401(k) matching Dental insurance Employee assistance program Health insurance Life insurance Paid time off Vision insurance Schedule:
8 hour shift Monday to Friday Education:
Bachelor's (Required)
Experience:
Quality assurance:
10 years (Required) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
OASIS Medical Inc.
Glendora, CA Glendora, CA Full-time Full-time $120,000 - $150,000 a year $120,000 - $150,000 a year Company Information:
OASIS is a continuous improvement company with an unwavering commitment to truth and accountability.
We believe in strategic partnerships, creating a quality eye care experience with solution-based products that result in long-term sustainability.
We are committed to a win-win approach to all that work with OASIS.
Our professionalism is demonstrated by our ability to think different.
Job
Summary:
The Quality Assurance (QA) Director plans and directs all aspects of the Company's product quality and 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.
Supervises team of Quality Assurance professionals including 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:
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 complaint 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; Provide 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 maintain 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 related technical field required; Minimum 10 years knowledge and experience in Quality Assurance; Ten (10) years' experience in supervision of Quality Assurance inspection activities; Minimum 5-7 years of QA Managerial level experience; Experience with sterile products and microbiology, including validation activities; Proven ability to maintain ongoing compliance in an environment regulated by Quality System Regulations and the Medical Device Directive.
Knowledge/Skills/Abilities:
General:
Demonstrate strong 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 effective 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; OASIS Medical is an Equal Opportunity Employer.
No third party responses please.
Job Type:
Full-time Pay:
$120,000.
00 - $150,000.
00 per year
Benefits:
401(k) 401(k) matching Dental insurance Employee assistance program Health insurance Life insurance Paid time off Vision insurance Schedule:
8 hour shift Monday to Friday Education:
Bachelor's (Required)
Experience:
Quality assurance:
10 years (Required) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
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