QA Engineer-CAPS

$71,832 - $89,795/Yr

Central Admixture Pharmacy Services - Wescosville, PA

Full-time - Entry Level

Wescosville, PA

10,001+ employees

Health and Personal Care Retailers

About the position

The QA Engineer at B. Braun Medical Inc. is responsible for establishing and reviewing quality standards for products and processes, ensuring compliance with industry regulations, and collaborating with cross-functional teams to mitigate quality risks. This role involves auditing production processes, conducting root cause analysis for quality failures, and applying statistical methodologies to validate processes. The position requires a proactive approach to quality assurance and a commitment to enhancing patient and clinician safety.

Responsibilities

• Review and establish quality standards for products and processes.
• Suggest modifications to prevent defects in components or final products.
• Work closely with cross-functional teams to identify and mitigate quality risks.
• Audit production processes, raw materials, or suppliers to ensure quality standards are met.
• Apply statistical methodologies for validation acceptance.
• Conduct root cause analysis for defects and non-conformities.

Requirements

• Bachelor's degree required or equivalent combination of education and experience; Master's degree preferred.
• 2-4 years of related experience required.
• Applicable industry/professional certification preferred.
• cGMP training/experience required.
• Valid driver's license and passport.

Nice-to-haves

• Experience in the healthcare or medical device industry.
• Knowledge of quality assurance methodologies and tools.

Benefits

• Healthcare coverage
• 401(k) plan
• Tuition reimbursement