Quality Engineer-NPI (Medical Device)

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Jawatan Kosong Posisi Quality Engineer-NPI (Medical Device) di SteriPack Asia Sdn Bhd

DESKRIPSI Jawatan Kosong

We are hiring a highly dedicated Quality Engineer–NPI who will manage specification, process validation, test method validation, stability study and transportation study at our Medical Device/Pharmaceutical sector.

Key Responsibilities: –

  • Manage the validation procedure (including equipment, process & test method) and validation master list.
  • Establishing validation documents and carry out validation activities including performance qualification and test method validation.
  • Conduct periodic validation review (PVR) in timely manner and perform revalidation when required.
  • Generate stability study documents and execute stability study as requested by customers.
  • As an admin to manage test equipment (such as tensile tester, smart scope, etc) and ensure the test equipment are operated according to requirement.
  • Revise raw material/product specification when required.
  • Identify and initiate improvement activities through analysis of data from manufacturing records such as capability study, risk analysis, etc.
  • Leading/supporting non-conformance investigation activities derived from internal/external including risk assessment, root cause analysis, implementing corrective & preventive action, etc.
  • Establish stability study and transportation study documents and execute as per customer requirement.
  • Provide support in internal, supplier and external audit process.
  • Keep abreast of new technology, have in-depth knowledge of products/raw material in order to provide technical support for new product introduction or improvement projects.
  • Comply with all approved standard operating procedures, work instruction and guidelines that had been trained on.
  • Attend to any other job as assigned by superior and complete the assignment given within the agreed time frame.
  • Assist and report all quality related matters to superior.

Key Requirements: –

  • Candidate must possess at least Degree in Science/ Chemistry Engineering or equivalent.
  • At least 3 years’ working experience, preferably in Medical Device industry.
  • Preferably candidate with good knowledge of ISO 13485, GMP and FDA 21 CFR Part.
  • Have similar experience working in cleanroom environment.
  • Able to work in a team and under minimum supervision.
  • Strong interpersonal, analytical and problem-solving skills.
  • Initiative, proactive, resourceful, able to multi-tasks and work independently.
  • Good written and verbal communication skills in English and Bahasa Melayu
  • Computer literate

You will be remunerated with Good Basic Salary based on experience and the following perks & benefits: –

  • Working with stable & well-established company.
  • Strategic location – safe environment
  • Performance Bonus
  • Annual Increment
  • Long Service Award
  • Birthday Gift
  • Attendance allowance
  • Medical Benefits
  • Group Insurance Coverage
  • Career Advancement Opportunities
  • Fair work life balance

Are you ready to make that career shift? Trust us, this role is always on-demand and you will grow a great portfolio with us. Click that ‘Apply Now’ button and we will talk to you soon.

Informasi Tambahan Jawatan Kosong

Tingkat Pekerjaan : Junior Executive
Kualifikasi : Manufacturing, Quality Assurance
Pengalaman Kerja : 3 years
Jenis Pekerjaan : Full-Time
Spesialisasi Pekerjaan : Manufacturing, Quality Assurance / 510, 197

Informasi perusahaan Pemberi Kerja, SteriPack Asia Sdn Bhd

SteriPack Asia Sdn Bhd

SteriPack Contract Manufacturing supplies the medical & pharma industries and offers ISO Class 8 cleanroom moulding / cleaning / assembly / packing and sterilization services of medical & drug-delivery devices. Our locations in Poland, Ireland, USA and Malaysia are cGMP / ISO13485/FDA compliant.

Product & Services

SteriPack Contract Manufacturing offers a complete range of outsourcing services from product concept to market launch including product design, process validation, product testing, supply chain management, product manufacturing, product assembly, product packing and sterilization management. All our products are manufactured in a Class 100,000 Cleanroom.

Informasi Tambahan Perusahaan SteriPack Asia Sdn Bhd

Ukuran Perusahaan : 51 – 200 Employees
Waktu Proses Lamaran :
Industri : Manufacturing / Production
Tunjangan dan Lain-lain : Medical, Regular hours, Mondays – Fridays, Business (e.g. Shirts)
Lokasi : Klang/Port Klang