Quality Engineer II — Medical Device Sustaining

SMC Ltd; Massachusetts; Sur place; USD 65 000 - 110 000; Plein temps

Avantages offerts par ce poste

Clean, Climate-Controlled Environment

Paid holiday and PTO

Health, dental, and vision insurance

401(k) retirement savings

Life and disability insurance

Promotional opportunities

Training and career growth programs

Employee Assistance Program

Résumé du poste

SMC Ltd. is seeking a Quality Engineer II to support sustaining projects within our medical device manufacturing operations in the United States.

You will collaborate with engineering, tooling and manufacturing to ensure proper processes, inspection methods, and quality tools are in place across molding and assembly. Responsibilities include maintaining DHR/DMR, conducting in-process and final inspections, and leading CAPA, FMEA, and control plan activities, while ensuring compliance with ISO

Qualifications

• Bachelor of Science Degree or Associate's degree with 5 years of experience
• 5-7 years’ of experience as a Quality Engineering within drug and medical device industries
• Must have experience with 21 CFR Part 820 Quality System Regulation
• Must have experience with 21 CFR Part 4 Combination Product Regulation
• Must have experience with ISO 13485
• Must be able to read and understand 2D detailed part/article drawings
• Must understand the use all Quality related inspection equipment
• Must have excellent problem solving and mistake proofing skills
• Must have computer skills and familiarity with Word and Excel programs
• Must have knowledge of SPC
• Effective interpersonal and problem solving skills
• Established track record in demonstrating strong leadership and managerial skills within a team-based, collaborative matrixed organization
• Excellent written, verbal, and presentation skills

Responsabilités

• To ensure Raw Material / Packing Material and finished goods testing in line with the SOPs
• To maintain device history records (DHR) & product release checklist for each lot
• To conduct inspections at in-process, in-coming and complete the final inspections
• To prepare technical documents like DMR & DHR
• To maintain microbial record in ISO class-7 & class-8 as per procedure
• Creating master documents to track calibration & latest version of documents and records
• To prepare control plan, FMEA & FAIR documents
• To prepare 8D and supplier CAPA reports
• Monitoring calibration activities
• Perform metrology activities & drawing reviews
• Coordinates investigation, root cause analysis & corrective action
• Preferred skills in various metrology equipment, such as VMS, CMM programming, etc.
• Product & process validation requirements & implementation
• IQ, OQ, PQ validation/qualification
• Working knowledge of the ISO 13485 & ISO 9001standards
• FAIR inspection, DHR & control of documents
• Good technical, analytical and trouble shooting skills
• Equipment experience with: VMS, CMM, Vernier caliper, micrometer, height gauge, etc.

Connaissances

Quality engineering

Problem solving

Leadership

Analytical skills

DOC control

Communication

Formation

Bachelor of Science or Associate degree

Description du poste

SMC Ltd. is seeking a Quality Engineer II to support sustaining projects within our medical device manufacturing operations in the United States.

You will collaborate with engineering, tooling and manufacturing to ensure proper processes, inspection methods, and quality tools are in place across molding and assembly. Responsibilities include maintaining DHR/DMR, conducting in-process and final inspections, and leading CAPA, FMEA, and control plan activities, while ensuring compliance with ISO