JobWatch

17 days old

Quality Engineer

Kelly Services
Roswell, GA 30077
**Quality Engineer**



**Position Purpose:**



Provides Quality/Regulatory and Medical Professional/Technical support for assigned quality systems, executing systems transactional work, routinely checking for compliance with standards, and providing limited training.



**Customers:**



Operations, Corporate Quality Assurance, Regulatory Affairs, Product Safety, Research & Engineering, Packaging, Legal, Marketing, Contract Manufacturers, Consumer Services, Clinical Affairs, Regulatory Agencies, Consultants.



**General Expectations and Accountabilities:**




+ Demonstrate safety as a value by performing all job functions safely, while also complying with corporate policies and departmental procedures, in an effort to reduce risk and eliminate loss.

+ Manages self in accordance with the expected behaviors of the Leadership Qualities. Effectively achieve results that meet business and individual objectives.

+ Ensures activities and items are in compliance with both company quality assurance standards and applicable government regulations, such as GMPs and ISO requirements.

+ Ensures that established manufacturing inspection, sampling and statistical process control procedures are followed, as applicable.

+ Performs production and quality systems audits.

+ Maintain and demonstrate an appropriate level of knowledge and skill in product forms, quality systems, processes, and regulations.

+ Establish and maintain good customer rapport, while driving solutions to meet business needs. Develop and maintain a strong spirit of partnership.

+ Conduct all communications and transactions with the utmost integrity. Communicate fully with superiors, teammates, and others who have a need to know.

+ Executes continuous improvement activities for established processes and initiates/supports development of new processes.

+ Builds and maintains capability in QMS, ISO, and GMPs to support objectives.

+ Work results have the ability to influence longer-term product or functional decisions

+ Requires independent completion of work, where judgment and discretion is required within the boundaries of the Post Market Surveillance end to end process



**Position Specific Accountabilities:**




+ Execute assigned Post-Market Surveillance activities, including Complaint Assessment, Investigation, Trending/Reporting, Decision Tree Completion, Final Review, and Sample Evaluation. Flow to Work to assist others as needed.

+ Act as the owner of one or more quality sub-systems (within Post-Market Surveillance), making recommendations and decisions on changes to standards, providing training to users, and supporting implementation as needed.

+ Identifies need for, develops, and executes continuous improvement plans for the assigned sub-system(s) to deliver business results.

+ Builds and maintains capability within the assigned sub-system for compliance with QMS, ISO, and FDA GMP's.

+ Responsible for providing Post-Market Surveillance support to assigned Mills and/or Product Forms via Standard Work, data analysis, and communication. Responsible for completing Level 1 & 2 Complaint Investigations on behalf of Mills.

+ Initiates and follows up on CAPA and QNC related to the assigned system.

+ Provide medical insight to assigned brands as well as supporting team requirements for preliminary medical assessment. Align opinions with Product Safety and Senior Medical Officer and escalate as needed.



**Scope:**



This position reports to SR. Quality Manager Post-Market Surveillance & Consumer Services. Has responsibility for execution of and record-keeping for quality systems in support of regulated products, with an emphasis on evaluating complaints using medical technical knowledge and escalating/communicating accordingly. Has responsibility for continuous improvement of quality sub-systems in support of regulated products and leads small to moderate-sized improvement projects.




**Why Kelly** **** **?**



Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2020-09-02 Expires: 2020-10-03

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Quality Engineer

Kelly Services
Roswell, GA 30077

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