Senior Quality Assurance Engineer
4 weeks ago
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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