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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:

  • Ability to document the analyses of product complaints for trends and identification of potential corrective or preventive actions
  • Recommend improvements in quality system to ensure that the quality system is efficient and effective controls are in place to

minimize risk.

  • Good documentation skills and attention to detail.
  • Complete projects in a timely manner and consistent with corporate objectives

QUALIFICATIONS:

  • Bachelor’s Degree
  • Minimum 5-7 years of Quality Assurance experience with at least 2 years in the medical device industry
  • Advanced problem-solving skills including troubleshooting and root cause analysis
  • Must be able to communicate complex technical issues clearly in English both verbally and in writing
  • Demonstrated understanding of medical device QMS requirements and regulatory requirements, including but not limited to ISO

13485:2016, 21CFR820 and MDSAP

  • Familiarity with risk management tools
  • Knowledge of quality system auditing; [auditing certifications (e.g. lead auditor, quality auditor, biomedical auditor) are a plus]

About Actalent

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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

  • Hiring diverse talent
  • Maintaining an inclusive environment through persistent self-reflection
  • Building a culture of care, engagement, and recognition with clear outcomes
  • Ensuring growth opportunities for our people

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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