Job Description Summary

He/she is a member of the TW/HK quality team reporting to the QA Head Taiwan & Hongkong.

This position oversees the Post Market Surveillance in TW/HK across all three Business Segments (Medical, Life Sciences and Interventional) supporting Sales, Strategic Key Accounts, Supply Chain including Distribution Centers & Distributors, Complaints management.

He/she will employ best practices and accelerate continual customer focused quality improvement into the organization, initiating lessons learned and best practice concepts to introduce pro-active improvement and prevent recurrence of issues.

Job Description

KEY RESPONSIBILITIES

Responsible for the development and continuous improvement of the Country Quality Management function and associates to the highest professional and performance standards. This includes appropriate training and accreditation to relevant professional standards, and participation in leadership and skill development training offered by BDU. He/she will promote and develop Diversity as a key element of high performance.

Employ best practices and tools to accelerate continual quality improvement, initiating lessons learned and best practice concepts; to introduce pro-active improvement and prevent recurrence of issues. Maximize the benefits for the overall system to drive compliance, business, and customer satisfaction.

Other or more specific responsibilities include: Management of Customer Complaints, Distribution Centers, Post Market  quality-related operations and, Quality System Documentation Management and Engineering Change Control (ECO) systems per BD Policies & Guidance, relevant Standards and local Regulation requirements. Organize and guide the collection and reporting of medical device adverse events, medical device recalls. Support business team with the sampling test activities and post market activities. Assuring adequacy and effectiveness of investigations/testing related to product complaints or internal failures, field actions, implementation of process improvements (eg, Six Sigma, Lean), including the feedback loop to the plant. Oversight of Quality Management Systems and processes to ensure compliance and alignment with all quality related local Regulations, relevant Standards, BD Quality Manual and Corporate Policies and Procedures. Ensure implementation of applicable Quality standards and governance processes.  Ensure effective execution of processes conducted under the Quality Systems to accomplish expected requirements and performance. Responsible for collecting, trending, analyzing and disseminating quality indicators, including but not limited to quality objectives, complaints, service levels, distribution and training. Support, in collaboration with Supply Chain, Regulatory and other responsible management and functions, of a BD Corrective/Preventive Action System and, direct responsibility for prioritizing and implementing corrective and preventive actions relevant to the effectiveness of the business Quality System to meet regulatory and business requirements. Engages and provides leadership directions/objectives, coaching and training and development for associates involved in Quality Systems to provide complete understanding and enable associates to meet the Quality objectives. Builds an influential and effective network and communication with Country Supply Chain & Regulatory, WW & Regional Quality, Plant Quality Managers, and other stakeholders as appropriate to escalate and resolve issues efficiently and effectively. Builds an influential and effective network in driving overall site performance, developing, and building a strong culture of compliance, Quality and Continuous Improvement. Sense, develop, facilitate, and execute post market quality compliance strategies/activities in TW & HK, ensuring the success of post market compliance such as Quality Complaints, Adverse Event Reporting, Field Actions and Recall in accordance with country and global company regulatory requirements. Oversee the establishment and maintenance of TW & HK Post Market Quality Compliance systems. Lead and /or facilitate and support Regional and Corporate Quality Projects.

POSITION REQUIREMENTS

Educational Qualifications & Previous Experience (Number of years as well as type of previous experience needed e.g. exposure to high growth markets, managed a large team etc.)

1.Basic Science degree/ Master’s degree or higher preferred. MBA is desirable.

2.Minimum 3 years’ experience in Quality Management at the specialist level in the medical device/healthcare industry and, at least 3 years Quality Management or Process Improvement experience in other manufacturing and/or service industries, which are recognized for supply chain excellence, design excellence and customer focus.

3.Experience working with metrics and performance indicators for continuous improvement.

4.Experience in constructing objectives, standards & procedures.

5.Experience working in a cross-functional and international multi-site environment.

6.Relevant experience in quality systems for complaint management, supply chain/warehouse, failure investigation, corrective & preventive action, and document & quality records management.

Black Belt in Manufacturing or Transactional Six Sigma, or equivalent in certification & experience is preferred.

Job Competency Requirements:

Comprehensive knowledge of Quality System standards and quality system related regulations including but not limited to Taiwan GDP. Quality Systems Track Record: Proven track record of significant accomplishments and innovation establishing progressive business practices with regards to quality. Strategic Thinker/Change Agent: High energy, accountable and forward-looking; able to see larger business picture.  Persuasive individual with the ability to work at all levels to educate and gain buy-in for Quality programs and initiatives; track record of creating a positive imprint on an evolving business; able to engage in strategic business discussion and communicate the value of Quality programs and initiatives and the value of change. Effective Trusted Communicator: Demonstrated ability to effectively educate and influence other stakeholders of the Quality System, encouraging ownership of quality vision and strategies; must be approachable, a good listener and trusted confidant. Exceptional Problem Solver and Manager: Must be a “working manager”, a practical as well as analytical thinker, able to identify and diagnose problems and craft realizable solutions.  Must be able to roll-up his/her sleeves to get things done, non-dictatorial; he/she must also be able to successfully establish objectives, manage people and projects, both directly and through influence and measure results to ensure accountability. Also, able to identify and alleviate any potential hurdles to achieving objectives.  Must be comfortable and able to operate within a matrix organization that thrives on teamwork and consensus building, not on authoritative, unilateral decision-making style.

Excellent communication skills. Fluent in English and Mandarin.

Required Skills

Optional Skills

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Primary Work Location

TWN Taipei - Zhong Xiao E Rd

Additional Locations

Work Shift