Supplier Quality Assurance Engineer
|April 04, 2018 - June 03, 2018|
|Location:||Salt Lake City, UT|
|Employment Type:||Full Time|
|Description:||About MasterControl |
MasterControl Inc. creates software solutions that enable life science and other regulated companies to deliver life-improving products to more people sooner. MasterControl's integrated solutions accelerate ROI and increase efficiencies by automating and securely managing critical business processes throughout the entire product lifecycle. More than 1,000 companies worldwide, ranging in size from five employees to tens of thousands, rely on MasterControl cloud solutions to automate processes for new product development, clinical, regulatory, quality management, supplier management, manufacturing and post-market surveillance. MasterControl solutions are well-known for being scalable, easy to implement, easy to validate and easy to use. For more information, visit www.mastercontrol.com.
The Supplier Quality Assurance Engineer will be entrusted with the duty of implementation and maintenance of the quality procedures within the organization. The Supplier Quality Assurance Engineer job responsibilities include safeguarding the quality standards set in the organization, conducting internal audits, hosting client and notified body audits, and managing approved suppliers. Provides development, implementation and maintenance of all quality management systems and support activities for the software development process. They maintain compliance while working together with other quality and training functions. The Supplier Quality Assurance Engineer should have excellent analytical and communication skills to properly plan, execute and administer audit-related processes.
MasterControl produces an electronic Quality Management System (eQMS) software for companies in the Life Sciences and other regulated industries. MasterControl uses its own software to administer its internal QMS. The eQMS is audited frequently by clients and notified bodies (ISO). The Supplier Quality Assurance Engineer will be directly involved in the administration of the MasterControl eQMS as well as the audit activities for the above-mentioned organizations.
|Duties:||ESSENTIAL DUTIES AND RESPONSIBILITIES:|
A comprehensive understanding of FDA regulations (ex: 21 CFR 210/211, 820, 58, and part 11) and ISO 9001, and the ability to break down requirements to establish credibility as a reliable information resource.
Establishes and maintains effective relationships with interdepartmental colleagues that support and promote the goals and objectives of the project.
Ensure compliance with all quality documentation within the organization.
Liaison between internal departments to ensure quality standards are met and provide suggestions for improvement of quality and best practices.
Conduct internal audits and submit quality audit reports to senior management.
Conduct/host customer and prospect audits, and provide audit feedback to management teams.
Provide reporting for any potential non-compliance areas and include potential recommendations or root-cause analysis.
Update Standard Operating Procedures (SOP's) for all documented processes company-wide. Partner with department managers to write SOP's for their standardized processes.
Identify areas requiring training and ensure gaps are completely-filled within given timeframes.
Prepare lists of deviations for correction and verify corrections are made as per established company standards.
Enhance quality across the organization and provide stable performance to customers.
Participate in local and cross-sectional improvement activities.
Support all Quality department functions, including: Change Control, Auditing, Validation Review, etc.
All other duties or assignments as assigned by Management.
|Qualifications:||KNOWLEDGE, SKILLS, AND ABILITIES:|
High level of accuracy and attention to detail
Communicate effectively in person, by phone, and in writing
Team player and a willingness to adjust priorities where needed
Ability to work independently or in a group
Professional demeanor and positive attitude
PHYSICAL DEMANDS AND WORKING CONDITIONS:
Ability to operate a computer and work at a desk for an extended period of time.
Walk and stand for extended periods of time.
Ability to lift up to 50 lbs.
Understanding of FDA and ISO regulations/standards
Bachelor's Degree (or equivalent degree or experience) is preferred
Minimum 4 years of relevant work experience required
Why Work Here:
MasterControl is a place where Exceptional Teams come together to do their best work. Hiring Exceptional Teams, including the best talent in our industry, is a core value of ours. MasterControl employees are surrounded by intelligent, motivated individuals every day. We like to call it #TheBestTeamOnThePlanet.
We value every employee and their contribution to what makes MasterControl successful. We give right back to the employee through a generous benefits package, great flexibility, and continuous opportunities for advancement.
Not only do we hire Exceptional Teams, but we work hard to keep them here by developing and challenging their skillsets, encouraging professional development and growth, and offering a culture that can't be found elsewhere. Which is why we say - #WhyWorkAnywhereElse?
To put it simply, working at MasterControl is fun, challenging, and rewarding. From our Fitness Clubs to our awards programs, from our company parties to our competitive benefits, you can't really go wrong. MasterControl could be your next (and last) career move!
We are growing quickly and always looking for talented individuals to add to #TheBestTeamOnThePlanet!
Here are some of the benefits MasterControl employees enjoy:
Generous PTO package of three weeks, increasing after just three years of employment
Competitive compensation with annual merit increase reviews
100% medical premium coverage (yes, you read that right!)
Employer Paid Life Insurance Policy ($50K)
Wellness Programs (every employee gets a Fitbit!)
Applicants must be currently authorized to work in the United states on a full-time basis.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.
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