Description:
The Quality Assurance department is devoted to assuring safe, reliable and effective products that exceed patient, physician and
hospital/clinic expectations. The department plays a vital role in product and process quality supporting commercial production for
all Iridex products including laser consoles, delivery devices and accessories.
The Quality Assurance (QA) Manager is responsible for managing and implementing the required actions to maintain existing
product lines and to solve any product quality issues while working with internal departments/business units to appropriately
remedy them. Responsibilities include strategic quality system insight and direction, quality systems management, management of
the Quality Systems Group, and budget management. Additionally, this role will help facilitate internal training on quality
assurance requirements, processes, and procedures.
MAJOR DUTIES AND RESPONSIBILITIES:
a) Proactively identifies areas for process improvements and collaborate with management to develop effective solutions
aligned with business objectives.
b) Manage and plan internal audits collaboratively with the Director of Regulatory Affairs.
c) Manage supplier quality assurance activities including but not limited to supporting new supplier approval, monitoring
performance of existing suppliers, and performing supplier quality audits
d) Perform analytical, statistical and trending analyses on complaint data to support timely management review and proactive
response or corrective action
e) Review/write product investigation reports. Provide analyses and trending data, including initiating formal investigations
and/or corrective action requests resulting from product complaints.
f) Ensures that the Quality Management System is established, implemented, and maintained in accordance with established
regulations (FDA, ISO13485, & other International requirements) as imposed and reports on the performance of the quality
management system to management for review and as a basis for improvement.
g) Evaluate existing quality system procedures and processes for compliance with applicable regulatory requirements
h) Develop formal written reports to communicate audit results to management and regulatory compliance agencies
i) Escalate to direct management all quality issues that could impact patient safety or surgical efficacy
j) Perform other duties as assigned by management
Skills:
Quality assurance, Gmp, Audit, Fda
Additional Skills & Qualifications:
JOB SKILLS:
minimize risk.
QUALIFICATIONS:
13485:2016, 21CFR820 and MDSAP
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
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The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
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