QA Manager, Greater China

QA Manager Greater China

Location Shanghai

Are you passionate about making life better for patients worldwide
If the answer is yes you think just like us. We are a world-leading medical solutions company designing and supplying medical solutions to enhance performance in healthcare from the hospital to the home. We are looking for people who want to improve outcomes for healthcare professionals and their patients.

Purpose of Position

Reporting to the QARA Manager Greater China.
Scope: Mainland China Hong Kong (Macau) and Taiwan.
The role serves as the Quality Responsible Person for the China joint venture legal entity and acts as the primary quality representative when interact with regulatory authorities.
The role provides oversight of quality and compliance activities across the product lifecycle including commercial operations outsourced service providers labelling and UDI compliance audits regulatory inspections and quality governance and any other customer-facing business quality activities across Greater China and accountable for ensuring compliance with applicable regulatory requirement and corporate quality standards.

What youll do

Quality Leadership and Regulatory Compliance

• Serve as the designated Quality Responsible Person for the China JV entity and provide primary accountabilities on all quality and compliance matters.
• Ensure compliance with applicable medical device regulations distribution quality requirements corporate quality standards and internal procedures.
• Support establishment maintenance and renewal of licenses permits and regulatory approvals required for business operations.
• Act as the primary quality representative during interactions with regulatory authorities and ensure timely escalation of significant compliance risks

Oversight of Commercial Quality Operations

• Provide quality oversight of all commercial activities related to the distribution and supply of medical devices.
• Ensure effective controls over product storage transportation traceability distribution returns and disposition activities.
• Oversee quality management activities associated with e-commerce pharmacies and other customer fulfillment channels ensuring compliance with applicable regulatory and company requirements.
• Ensure appropriate quality review and approval of activities that may impact product quality safety or regulatory compliance.

Product Compliance and Lifecycle Quality Management

• Ensure compliance of product labeling packaging UDI traceability and related product information throughout the product lifecycle.
• Provide oversight of post-market surveillance activities including complaint handling adverse event reporting field safety corrective actions recalls and product quality investigations.
• Ensure emerging quality signals and risks are appropriately assessed escalated and addressed.

Management of External Service Providers and Suppliers

• Establish and maintain effective quality oversight of outsourced activities including logistics providers warehouses transportation partners and other service providers.
• Ensure supplier qualification quality agreements performance monitoring periodic reviews and audit activities are implemented and maintained.
• Drive continuous improvement of supplier and service provider quality performance through risk-based monitoring and governance.

Audit Inspection and Quality Governance

• Lead or support internal audits supplier audits corporate audits and regulatory inspections.
• Ensure timely and effective responses to audit observations inspection findings and quality system deficiencies.
• Provide quality performance reporting and compliance status updates to management and participate in management review and quality governance activities.
• Promote a risk-based approach to quality management and decision making across the organization.

Support continuous improvement initiatives and drive actions to enhance quality system effectiveness and operational compliance.

What youll get

Competitive salary depending on experience
Annual bonus
Monthly allowance
Annual holiday plus bank holidays
Life assurance and Income protection
Genuine career longevity and professional development opportunities
Employee Assistance Programme

What youll decide

The position is authorized to:

• Determine and escalate quality and compliance risks that may impact product quality patient safety business continuity or regulatory compliance.
• Approve or reject the qualification continued use and performance status of external service providers including logistics providers warehouses and other quality-critical suppliers.
• Approve quality disposition decisions related to product storage distribution returns nonconforming product and other quality-related operational activities within delegated authority.
• Approve quality agreements and quality requirements applicable to outsourced activities.
• Represent Quality in regulatory inspections audits and communications with health authorities and approve related quality responses and remediation plans.
• Determine and recommend appropriate actions for quality events including complaint investigations adverse event assessments field safety corrective actions recalls market withdrawals and product holds.
• Review and endorse quality performance metrics management review inputs and quality improvement initiatives.

What youll need

• Strong cross-functional collaboration and communication skills with the ability to drive quality and compliance decisions across a matrix organization.
• Demonstrated ability to balance regulatory compliance business needs and risk management through a pragmatic and risk-based approach.
• Experience managing quality oversight of outsourced activities including logistics providers warehousing operations distributors suppliers and other third-party service providers.
• Solid experience supporting regulatory audits and authority inspections with familiarity in distributor and supply chain quality management including GSP-related requirements.
• Experience participating in management review quality governance quality metrics review and quality risk management activities.
• Strong sense of ownership and accountability with a proactive mindset and high commitment to quality and inspection readiness.
• Familiarity with e-commerce pharmacy and other customer-facing distribution models is preferred.
• Bachelors degree in life sciences biomedical engineering quality management or a related technical discipline.
• Minimum of 8 years of experience in quality assurance within the medical device or pharmaceutical industry.
• ISO 13485 Internal Auditor or Lead Auditor certification is preferred.
• Good command of English and Chinese for documentation and communication.
• Experience working in a multinational company.
• Experience with design control/Design QA is an advantage.

Any other information

The role may assume additional responsibilities based on organizational structure business expansion and evolving regulatory expectations.
Regular interaction with regulatory authorities and external stakeholders is expected.
Occasional business travel may be required for distributor audits inspections regulatory meetings or project support.

Additional Responsibilities

Participate in adhoc regulatory or compliance projects as assigned.

Flexibility to support urgent quality or regulatory issues outside standard working hours when necessary.

ABOUT MOLNLYCKE

Mölnlycke is a world-leading medical solutions company. We design and supply solutions to enhance performance at every point of care from the hospital to the home proven it every day.

We specialise in:

Wound management: including dressings with Safetac such as Mepitel and Mepilex
Preventing pressure ulcers: with Mepilex Border used prophylactically and devices to help turn and re-position patients.
Surgical solutions: including Mölnlycke trays HiBi antiseptics and Biogel surgical gloves.

Mölnlycke was founded in 1849. Nowadays our solutions are available in around 100 countries; were the number one global provider of advanced wound care and single-use surgical products; and were Europes largest provider of customised trays. Our headquarters are in Gothenburg Sweden and we have about 7800 employees around the world.