Quality Engineering Manager
2 weeks ago
**Careers That Change Lives**
**Medtronic Singapore Operations** was among the **first international medical technology firms** to set up manufacturing operations in Singapore. We are one of the **most advanced **medical device manufacturing sites and the first manufacturing facility of its kind in the region to make **implantable cardiac leads, pacemakers and monitors.**
**Our Purpose**
Founded in 1949, our **Mission** continues to serve as our ethical framework and inspirational goal for our employees around the world. It guides our day-to-day work and reminds us that our efforts are **transforming the lives** of millions of people each year. If you have a passion for medical device manufacturing, this opportunity could be for you
**Quality Engineering Manager**
**A Day in the Life**
- Responsible to assure that manufacturing processes comply with the product specification and regulatory government agencies requirements.
- Provide mechanisms for controlling the total quality and establish ways of evaluating the quality of our products.
- Participate on internal, inter-facility and vendors/suppliers quality audits to determine the extent of compliance and effectiveness of operations, to documented policies, procedures, specifications, FDA and ISO requirements.
- Drive the Manufacturing operations initiatives, qualification and validation activities for product or technology transfers.
- Lead Quality improvement initiatives and align the organization to meet Quality goals and Objectives.
Key Responsibilities:
- Assure that processes comply with specifications, Quality Systems Regulations and ISO standards.
- Manage and supervise a team of ten or more direct reports who are focused on tactical, operational and some strategic activities within quality department.
- Oversee Quality Engineering team functional roles, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports
- People management responsibilities: accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals.
- Participate in the quality council from corporate and being the leader to represent MSO for this council.
- Work with Engineering and Manufacturing to ensure product meet specification and requirement.
- Establish mechanism to evaluate, measure, monitor and/or quality in our products.
- Evaluate product/material discrepancies. (PRB/MRB) on time, and implement corrective actions accordant.
- Work on process improvement and actively participate in the qualifications and validations of product/equipment and processes.
- Essentially to understand product and process requirements, striving for standard process acceptance where requirement is fully understood, practical and effectively followed/controlled.
- Develop improvement plan and execution to match MSO quality standard and ramp up criteria.
- Responsible for all aspects of process control with the specific objective of improving product quality.
- Leading and participation in continuing process performance improvement activities locally or globally through meeting with Process Owners and Management to outline goals set for each process.
- Works and implements special improvement assignment/projects as assigned by Direct Supervisor.
**Must Have: Minimum Requirements**
- Bachelors degree required
- Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience
**Nice to Have**
- Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area. Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization.
- Preferably in a quality assurance or test related capacity.
- Good written reporting skills and excellent English (oral and written reporting skills).
- Able to multi-tasking and willing to take challenges.
- Good communication skills to leverage multicultural and multi-departmental teams.
**About Medtronic**
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our
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