Quality Engineer
Medica USA is looking for a motivated Quality Engineer. The candidate will understand how to identify nonconforming products and investigate to identify the root cause of issues. Specifically, this position will investigate nonconforming devices to identify failure modes, collaborate to write and implement process improvements based upon the failure analysis results, and report on failure trends. In addition, this role manages suppliers to ensure they are qualified as per quality system requirements, provide materials of high quality that meet specifications and implement pro-active preventive measures when needed. The candidate will also support and help develop pfMEA; conducts risk analysis where applicable, maintains risk management files and support and works cross functionally, specifically, supports engineering and guides engineering as well as operations in accordance with 21 CFR regulations/ISO 13485.
Responsibilities:
- Develop SOPs and maintain processes for documenting product requirements, specifications, verifications, and validations.
- Collaborate with internal and external stakeholders to develop business and customer needs for product development and manufacturing.
- Resolution of supplier quality issues and management of supplier quality performance -- SQP management, PIQ/PPM metrics, Support for new program launches -- Tech Review, Quality Risk Assessments (QRA).
- Documentation management and process validation.
- Quality control (membrane extrusion) + lab testing.
- Clean room management and monitoring.
- Work in conjunction with engineering regarding instruments calibration.
- Training of the personnel while working in conjunction with Medica S.p.A.
- Work cross functionally to maintain equipment and machines.
- Facilitate incoming inspections of final products.
- Identification / traceability / preservation of the products (warehouse).
- Management of nonconformities / CAPA.
- Management of nonconforming products.
- Work cross functionally to review local suppliers’ selection and evaluation.
- Assistance to Medica S.p.A. for product complaints management and regulatory activities.
- Additional quality activities as needed.
Qualifications:
- B.S. in engineering
- 2+ years’ experience in process development or manufacturing process engineering
- Experience developing and validating medical device manufacturing processes and technologies with an emphasis on design for manufacturability preferred.
- Interpret and implement specifications
- Strong mechanical system troubleshooting and general aptitude
- Micro controls/analysis experience preferred but not required
- Quality mindset, and ability to identify quality-focused continuous improvement opportunities. Passionate about improving product quality
Salary :
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