Lowongan Kerja Semarang Posisi Quality Management Head di Hirea Group Bhuana

Info Loker

Perusahaan	Hirea Group Bhuana
Posisi	Quality Management Head
Tempat	Semarang
Jenis Pekerjaan	Full Time
Spesialisasi Dibutuhkan	Penjaminan & Kontrol Mutu (Manufaktur, Transportasi & Logistik)
Gaji Min	Rp. 25.075.000
Gaji Max	Rp. 35.075.000

Job Title: Quality Management Head (Quality Head)

I. Core Value of the Position

We are seeking an expert capable of building a quality system from the ground up (0 to 1) and leading its ongoing pursuit of operational excellence. You will be not only the guardian of the system but also a strategic partner to the business. By establishing a solid foundation for product quality, you will ensure compliant and efficient company operations, driving the company to win trust and achieve growth in a competitive market.

II. Key Responsibilities

• Quality System Strategy & Development

• Lead the design, implementation, maintenance, and continuous improvement of an integrated Quality Management System covering the entire company, ensuring compliance with applicable regulatory standards such as ISO 13485 / GMP / ISO 22716.

• Act as the core owner of the management system, ensuring its effective operation throughout the organization and preparing for various official and third-party audits.

• Product Lifecycle Quality Assurance

• Lead quality planning for new product introductions, overseeing the entire process from R&D, technology transfer, and commercial production to market release.

• Take overall responsibility for product quality, including quality planning, quality control, quality improvement, and leading customer complaint investigations, deviation handling, and risk management activities.

• Compliance & Registration Support

• Ensure that the entire process of product production, testing, and release complies with registration standards and regulatory requirements. Provide crucial quality system support and documentation for product registration and certification in domestic and international markets.

• Team Leadership & Talent Development

• Be responsible for building, managing, developing capabilities, and conducting performance evaluations for the entire quality team (QA/QC), fostering a high-performing, professional team with a strong quality mindset.

• Internal & External Collaboration for Operational Excellence

• Organize, coordinate, and support the work of various internal departments (R&D, Production, Supply Chain, etc.) to ensure effective product quality control.

• Serve as the primary quality interface, responsible for effective communication and management regarding quality matters with suppliers, external manufacturing partners, regulatory authorities, and customers.

III. Qualifications & Requirements

Must Have:

• Bachelor’s degree or higher in Pharmacy, Chemistry, Bioengineering, or a related STEM field.

• 7+ years of quality management experience, with at least 2 years in a Quality Department Head or Manager-level position.

• Proven experience in leading the complete project of building a Quality Management System from scratch (0 to 1) and successfully obtaining certification within at least one of these industries: Medical Device, Pharmaceuticals, or Cosmetics.

• In-depth knowledge of core quality regulations and standards such as ISO 13485 / GMP, with substantial hands-on experience in internal and external audits.

• Strong English language skills, capable of being used as a working language for written communication and meetings.

• Proficiency in using office software and quality management-related software systems.

Preferred to Have:

• Experience with multi-plant or multi-country quality project management or system integration.

• Management experience in areas such as In-Vitro Diagnostics (IVD), sterile medical devices, or complex formulation cosmetics.

• Familiarity with the regulatory requirements of major markets such as EU MDR/IVDR, US FDA, or NMPA.

Lamar kerja

Deskripsi Perusahaan

Info Perusahaan

• Industri: