The primary objective will be to support Quality Projects and Initiatives managed by the organization to meet their objectives in acquiring highest quality systems and materials (parts, sub-systems, final assembly, outsourced products, services, audits, etc.) in two main focal areas: component risk assessment and control plans in compliance with Corporate Policy 019 “Supplier and Purchasing Controls”.
Responsibilities will include interfacing with a broad range of cross-functional and cross-facility personnel, and leading/executing projects of small/medium scope in the role of project manager.
Project execution may require the utilization of Engineering skills. Project execution also requires that the candidate demonstrate significant interpersonal skills, interfacing with individuals from purchasing, manufacturing engineering, quality engineering, and production; as well as direct communication and interface with CRDM Suppliers.

RESPONSIBILITIES

The primary objective will be to support Quality Projects and Initiatives managed by the organization to meet their objectives in acquiring highest quality systems and materials (parts, sub-systems, final assembly, outsourced products, services, audits, etc.) in two main focal areas: component risk assessment and control plans in compliance with Corporate Policy 019 “Supplier and Purchasing Controls”.
Responsibilities will include interfacing with a broad range of cross-functional and cross-facility personnel, and leading/executing projects of small/medium scope in the role of project manager.
Project execution may require the utilization of Engineering skills. Project execution also requires that the candidate demonstrate significant interpersonal skills, interfacing with individuals from purchasing, manufacturing engineering, quality engineering, and production; as well as direct communication and interface with CRDM Suppliers.
Key Accountabilities:
Component Risk Assessment:
Follow applicable internal green level procedure and other applicable policies and procedures in the performing component risk assessment.
Interface with a broad range of cross-functional and cross-facility personnel in using:
The list of purchased components use for the clinical and manufacturing of finished devices intended for human use.
Applicable quality records to define component quality risk. Quality records may include but is not limited to outputs of: critical feature identification (CFI), failure mode and effect analysis FMEA (manufacturing, suppliers, etc.), component qualification, severity rankings and key characteristics worksheets.
Analyze data and information retrieve to define and documenting component quality risk as per applicable internal procedures.
Translates procedures scales to the overall supplier risk scale included in the Corp policy 019 “Supplier and Purchasing Controls as needed.
Perform periodic reviews and updates to components risk assessments that may be driven by business conditions or as a result of a newly supplied product being added that increases the risk level or if products have been removed from the supplier’s portfolio that may reduce the overall quality risk.
Control Plans:
Follow applicable internal green level procedure and other applicable policies and procedures in the review or development of control plans.
Interface with a broad range of cross-functional and cross-facility personnel including the suppliers in performing:
o Guide supplier in the development or review of control plans.
o Approve supplier control plans
o Help supplier:
1. Identify minimum characteristics and supplier process stages to be included in the control plans.
2. Define applicable special processes that requires control plan.
3. Identify Sub-tier suppliers that requires control plans.
4. Review and approve alternate control plans methods chosen by of supplier’s other than those described in this specification.
5. Make sure that control plans are living document, meaning it should be developed and revised to reflect the addition/ deletion of controls and measurement systems.
6. Make sure that initial control plan and subsequent proposed revisions with significant changes should be submitted to and approved by the appropriate facility quality and/or engineering program personnel thought applicable change control process.
Train suppliers in internal procedures such as: Control Plans (including form), record retention policies and process validation for special processes.
General responsibilities:
Support other Continuous Improvement projects that require basic Engineering and Project
Management skills driven by process excellence thinking and actions throughout the organization.
Routinely work with suppliers/clients, MDT sourcing and/or MDT procurement functions to define new opportunities and improve perceived gaps in process performance.
Establish and successfully execute our supplier management and development plans which will align to overall business objectives.
Communication of expectations, in collaboration with MDT sourcing and/or MDT procurement functions, for continuous improvements and providing leadership for improving the supplier relationship. Work with them constructively to improve their performance levels.
Perform thorough supplier audits and assessments of their processes and QMS and drives improvement.
Demonstrate knowledge of national and international requirements and standards such as FDA QSR Part 820, ISO 14971, ISO 13485, ISO 9001, CMDCAS/CMDR and others.
Create or revise any procedure or documentation required to improve quality control between our suppliers and our company.
Travel may be required in order to perform supplier assessments and development.
Perform other duties as assigned.
Attributes:
Good adaptation to the stress.
Flexibility and adaptability.
Team work.
Desire to learn new processes.
Capacity to transmit a knowledge/know-how.
Patience and perseverance.
Results/milestone oriented, motivated by achievement.

DESIRED SKILLS AND EXPERIENCE

Bachelor’s Degree in Science with emphasis in Engineering, Materials, Quality Assurance, or Quality Systems.
Minimum 3-5 years relevant experience in supplier quality.
Advanced education in technical/engineering area.
Working knowledge of FDA QSR’s, ISO-9001 and/or ISO-13485.
Engineering tools utilization experience such as design of experiment, risk management,
validation and statistical analysis. ASQ Certified CQE, CQA or CRE is an asset.
6 Sigma Green or Black Belt is also an asset.
Effective verbal and written communication skills in order to effectively communicate with internal customers and suppliers, and to develop and present communication plans and strategies.
Strong computer skills

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