were 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. 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, indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?
Theres 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.
Requirements: 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
This position is open to all candidates.