MedTech Quality Engineering Manager

bdx

Columbus (NE)

On-site

USD 110,000 - 170,000

Full time

14 days+

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Job summary

BD seeks a senior Quality leader to manage Quality Systems and Quality Engineering for the Columbus BU. You will drive validation activities, CAPA, and continuous improvement while guiding a cross-functional team to meet BD Medical: Medication Delivery Solutions quality objectives.

You will oversee regulatory compliance, lead audits, and champion customer-centric quality improvements in a 24/7 operation environment.

Qualifications

BS in engineering or science; minimum 5 years in quality with 3+ years in medical device industry.
Experience with validations, CAPA and statistical analysis.
Experience with high-volume manufacturing processes.
Experience in Lean/Six Sigma.
Proven ability to manage and lead people; strong communication under pressure.

Responsibilities

Leads the Quality Systems and Quality Engineering activities for the designated BU.
Supports validation activities for processes, products, materials and projects.
Implements strategic direction for QA aligned with BD Quality strategy.
Provides leadership to BU BLT and Columbus Quality leadership team.
Drives continuous improvements and customer-centric quality improvements.
Oversees CAPA program to reduce customer complaints and waste.
Interfaces with regulatory bodies and leads internal/external audits.