Quality Assurance Engineer in Manufacturing
2 months ago
Manufacturing Quality Engineer (Contract)
KEY RESPONSIBILITIES
- Designing, executing, and refining manufacturing methodologies to optimize yield, minimize expenses, and boost operational efficiency.
- Acting as the Process Engineering representative in Research & Development and Project Team discussions, offering technical insights on technology transfers, analytical method formulation, validation, and process scaling.
- Overseeing or conducting process validations (IQ/OQ, OQ, PQ).
- Diagnosing and resolving production line challenges concerning yield, quality, and throughput.
- Facilitating the transition of processes from development stages to large-scale manufacturing.
- Assisting in the assessment of Non-Conformance Material Reports (NCMR), Corrective and Preventive Actions (CAPA), Supplier Corrective Action Requests (SCAR), Failure Investigations, and Deviation inquiries from Contract Manufacturers/Suppliers.
- Generating and revising manufacturing guidelines, routing documents, bills of materials, and Standard Operating Procedures (SOPs).
REQUIRED QUALIFICATIONS
- At least 4-5 years of experience in the medical device manufacturing sector.
- Proficient in Design Transfer and Process Validations with external suppliers (Contract Manufacturing Organizations).
- Ability to draft and implement related validations.
- Strong analytical capabilities and problem-solving proficiency (Design of Experiments, Statistical Process Control, Six Sigma).
- Familiarity with Class II/Class III medical device manufacturing and associated quality system regulations.
- Proven track record of meeting deadlines, demonstrating effective project planning and management skills.
- Exceptional verbal and written communication abilities; adept at engaging with both technical and non-technical stakeholders.
- Capability to provide clear direction and support to external partners and suppliers.
- Experience with electromechanical assemblies is advantageous.
- Background in Design for Manufacturing is preferred.
- Experience in fixture development is a plus.
- Exposure to early-stage product development is desirable.
EDUCATIONAL BACKGROUND
- Bachelor's degree in Biomedical Engineering, Manufacturing Engineering, Mechanical Engineering, or a related life sciences field.
- Six Sigma Certification is preferred.
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