QC Inspector

Description

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Job Summary

The Quality Control Inspector role is essential in ensuring incoming, in-process and finished medical devices meet specifications. The Quality Control Inspector provides total manufacturing quality inspection services including quality inspection, quality control, sampling inspection, documentation and record review and approval. Adhering to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) is essential to maintain all documentation necessary to ensure conformity to specifications and traceability of records.

Essential Duties And Responsibilities

• Responsible to perform set-up, in-process dimensional and visual audits to ensure compliance to all specifications and DMR. Responsible to record all the test results and the activities in the relevant documents as part of the DHR
• Responsible to verify that all acceptance test results meet the requirements according to the procedures and specifications.
• Responsible to verify that all acceptance test results follow GMP and GDP guidelines. Conform with and abide by all regulations, policies, work procedures, instruction, and safety rules.
• Responsible for the approval of line clearance at the production lines, testing stations and cleanroom.
• Responsible for approving raw materials.
• Responsible to verify stored raw material, approved devices and subassemblies and rejected materials are identified and traceable as required in applicable procedures and specifications.
• Responsible for nonconformities handling inside the production room and for the MRB cage at Raanana warehouse.
• Responsible for incoming inspection for R&D items and materials that are in use to support devices samples build sand meet customer demands during development stages.
• Determine whether a Non-Conformance (NCR) has occurred and follow established procedures to initiate corrective actions.
• Perform other duties as assigned based on business needs.
  
  

Basic Qualifications

• Education- Technical/ Practical Eng.- an advantage
• At least 2 years of relevant experience in Quality in the Medical Device/pharma industry
• Courses related to Medical Device regulation- an advantage
• Knowledge with ERP/ SAP- an advantage.
  
  

Preferred Knowledge, Languages, Skills And Abilities

• Ability to work under pressure
• Good interrelation skills
• Technical ability- ability to read technical drawings
• Creativity
• High Learning ability
• Organized
• Ability to prioritize
• Excel -basic knowledge and experience.
• Written and verbal communication skills: Hebrew- Mother tongue. English- Good
• Relevant work history and/or experience may be considered in lieu of degree
  
  

Travel Requirements

• Must be able to travel up to ____0___ % of the time
  
  

Competencies/Authorities

• Affix Approval / Rejection labels of raw material
• Approval the beginning of the production (FAI)
• Record and Handling of tests results In process and final reports
• Sending the final DHR to MQ Team leader
• Preparation of a sample of raw materials for incoming inspection tests
• Release raw materials from the MRB cage
• Approval of the line clearance
• Interim stop production
  
  

Physical & Mental Requirements

• Very Heavy/ Heavy/ Medium/ Light/ Sedentary: ___________________
  
  

Delegation/s (Title)

Qualified personnel

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to [email protected] . Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.