62 applicants
SunTech · 2 days ago
Quality Engineer
Morrisville, NC
Full-time
Onsite
Mid Level
3+ years exp
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Hiring Manager
Ajit Anthony
Insider Connection @SunTech
Responsibilities
Leads the work on moderately complex problems including analysis of data, root cause analysis and design of experiments.
Ensures regulatory requirements and process/product goals are met across all projects.
Supports Quality Systems such as delivery holds, internal and external audits, CAPA and investigations. Assists in creation and management of changes to specifications, batch records, process requirements, and nonconformance reports.
Leads customer complaint investigations related to design and manufacturing related issues
Works creatively and analytically in a problem-solving and process-oriented environment. Expected to operate independently, holding him/herself accountable to proactively fulfill tasks and achieve results within assigned timelines.
Prepare trending reports to promote corrective action and continuous improvement.
Assists in the qualification, setup, monitoring and change management of suppliers for the procurement services/goods/raw materials including supplier evaluations and supplier CAPA investigations.
Acts as the Quality SME for new product development projects.
Other duties as assigned.
Qualification
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Required
BS degree in Engineering or equivalent
3-5 years of relevant experience, preferably in the medical device industry
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint)
Proficient in SPC tools and techniques
Excellent oral and written communication skills, including strong technical writing expertise
Must have experience in protocol development, execution and reporting for equipment qualifications (IQ/OQ/PQ), processes and system validations
Experience with leading cross functional teams as the quality expert
Thorough understanding and prior experience working in an FDA regulated environment
Preferred
Knowledge of EU MDD/MDR, ISO 13485, 21CFR820 and ISO 14971 highly preferred
Company
SunTech
SunTech, a Halma company, has been the preeminent supplier of clinical grade blood pressure monitoring products and technologies for more than 30 years.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2012-05-31Acquired· by Halma
Leadership Team
Ajit Anthony
Human Resources Business Partner
Company data provided by crunchbase
