BioTalent ยท 2 days ago
Senior Quality Engineer
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Responsibilities
Design, document and implement methods for process control, process improvement, testing and inspection.
Conduct root cause analysis as needed, utilizing applicable tools to ensure robust solutions or improvements are determined and implemented.
Facilitate and lead CAPA meetings.
Lead appropriate advanced product quality planning (APQP) processes within the organization to ensure product and process validation and verification.
Work with engineering team using past performance data to prevent future occurrences. Utilize tools such as DOE, DFM, FMEAs, GD&T, process capability, 6-sigma designs, etc.
Qualification
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Required
3-5 years in a relevant position + BS in an engineering capacity
Experience in regulated, relevant environments (FDA 21 CFR Part 820, ISO 13485, ISO 14971, etc.)
Preferred
Certified Quality Engineer
Experience with audits, preferably within an ISO 13485 environment
Benefits
Annual Bonus
401(k)
Company
BioTalent
BioTalent is life sciences recruitment agency with international reach and unrivalled knowledge & expertise.
Funding
Current Stage
Growth StageCompany data provided by crunchbase