Senior Quality Assurance Engineer

2 days ago


Houston, Texas, United States Alcon Full time
At Alcon, we're driven by meaningful work that helps people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. As a Quality Assurance Engineer II, you'll be recognized for your commitment and contributions, and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Quality Assurance Engineer II, you'll support our Quality Assurance Engineer Team, focusing on developing, modifying, applying, and maintaining quality evaluation and control systems/protocols.

**Key Responsibilities:**

* Conduct quality assurance tests and perform statistical analysis to assess the level of control and manage product quality risks.
* Undertake root cause analysis of incidents requiring corrective action.
* Ensure that corrective measures and deviation meet acceptable reliability standards and that documentation is compliant with requirements.

**Complaint Closure:**

* Review new files, initiate and perform preliminary investigation within procedural timelines.
* Perform peer review for file closure to ensure independent review of investigations and quality summaries.
* Assist with complaint sample in-take and sample testing.

**Trending:**

* Facilitate Customer Complaint meetings as needed, create quality performance slides summary slides, assist with Customer Experience meetings, and provide ad hoc data for different departments as requested.

**Regulatory:**

* Provide regulatory responses for product family specific requests.

**Quality Systems procedures:**

* Support Audits as a SME and/or Supporting Role, Lead/co-Lead Monthly Japan Quality Assurance Meetings, maintains complaint investigation root cause analysis templates for on-going or open CAPAs or QIE investigations and lead and/or support other duties as assigned.

**Purpose:**

* Lead activities involving complaint investigations, product impact assessments for events, product review activities, complaint trending, non-conformance reporting/issue resolution and procedural updates to ensure the process and documentation is compliance with 21CFR820, ISO, and other regulatory requirements as well as internal requirements.

**Requirements:**

* Bachelor's Degree or Equivalent years of directly related experience (or high school +8 yrs; Assoc.+4 yrs)
* The ability to fluently read, write, understand and communicate in English

**Work hours:**

* Monday through Friday / 8:00am - 5:00pm

**Travel Requirements:**

* 0 to 10%

**Relocation assistance:**

* No

**Sponsorship available:**

* No

**How you can thrive at Alcon:**

* Collaborate with teammates to share standard processes and learnings as work evolve
* See your career like never before with focused growth and development opportunities
* Join Alcon's mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career
* Alcon provides robust benefits package including health, life, retirement, flexible time off for exempt associates; PTO for hourly associates, and much more

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