Quality Engineer 2, Product Quality Assurance

Position Summary

Supports the Product Quality Assurance team analyzing post-market data and potential product quality issues for commercialized devices.  Accountable for a broad range of technical assignments in the Quality Assurance area under general supervision and working with cross-functional investigation teams. Understands the fundamentals of root cause investigation, risk management, and medical device Quality Management Systems per 21 CFR 820, ISO 13485 and 14971. 

Principal Responsibilities

•    Create, investigate and/or manage nonconformances, as well as associated ship holds and product disposition 
•    Investigate, compile and report on information necessary for executive management to assess if field actions/corrections and removals associated with Teleflex products is warranted. 
•    Work closely with Manufacturing sites, R&D, Suppliers, Supplier Quality, Marketing, Design Assurance, and Regulatory to investigate and document quality issues.
•    Assist with compilation and analysis of product quality metrics for presentation to Global and business unit leadership. 
•    Utilize statistical techniques to identify rates, changes in trends or estimated occurrences based on bench and field data.
•    Utilize sound technical writing to provide clear and concise written internal reports and support external communications as needed to respond to Product Quality issues 
•    Assist during regulatory inspections and/or audits and present as required
•    Utilize SAP, Agile and other systems as warranted for data input and quality record maintenance.  
•    Communicate and escalate Quality issues appropriately to QA Manager and address other items as assigned by Manager. 

Education / Experience Requirements

•    BS Degree in Engineering (or related technical field)
•    2-5 years related (medical device preferred) experience 
•    Experience with statistical analysis using Minitab and/or Microsoft Excel.
•    Quality Assurance (21CFR820, ISO13485) and Risk Management (ISO 14971) experience desired
•    Experience with Corrective Action and Nonconformance process

Specialized Skills / Other Requirements

•    Quality Assurance (21 CFR 820, ISO 13485) and Risk Management (ISO 14971) experience required
•    Experience with Corrective Action, Manufacturing and Design Control concepts desired.
•    Computer literate (i.e., statistical software and analysis, excel, word processing for report generation, PowerPoint presentations, etc.).

•    Positive attitude and ability to operate and communicate effectively with multiple teams & leadership.
•    Ability to reason, support and prioritize projects, adapt to shifting priorities, effectively solve problems / conflicts, and proactively effect change.

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The pay range for this position at commencement of employment is expected to be between $82,600 - $123,900; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
 
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.