Smiths Medical
Position Summary
Under the general guidance of the Senior Director, Quality Engineering, this position ensures new product development Quality Engineers and their associated project teams utilize appropriate engineering and scientific analyses and processes during the product development/qualification and commercialization process for ICU Medical electromechanical products, including Infusion Pumps and Temperature Management devices. He/She will work directly with Quality Engineers to provide guidance and direction relating to pipeline and on-market product development teams. This individual will be responsible for the plan and implementation of the Quality System and Medical Device standards related to product development and on-market devices, to ensure compliant, safe and effective products. Will manage new product offerings and product life cycle management by assuring adequate completion of qualification activities, compliance with ICU Medical's quality system and overall strong product documentation record.
Essential Duties & Responsibilities
Provide effective tactical Quality leadership for Quality Engineers.
Interact and communicate with Senior Leadership across ICU Medical regarding program status, risks, mitigation plans and business objectives
Effectively deploy and assure compliance with ICU Medical's Quality System such as Design Controls, risk analysis/management tools, design verification, design validation, investigations, CA/PA data, etc. to assure product quality
Support design and manufacturing site inspections/audits, representing and defending Design Control compliance for medical device products
Assure systems conform to all applicable US and international regulatory requirements and coordinate development of data and responses for regulators
Understand medical device regulations and assure ICU Medical Quality Systems and documentation remain compliant
Ensure all Quality attributes for design changes and fixes are met. Work with cross-functional teams to coordinate product changes
Provide design quality support, guidance and direction for all manufacturing facilities including driving/managing on-market product issues to closure and escalating to senior management for support as necessary
Define, evaluate, prioritize and correct potential product and process risks to drive continuous quality improvements
Represent the Quality organization as the core team member on Platform/Business teams
Work with on-market teams regarding product life-cycle management and change management
Knowledge, Skills & Qualifications
Demonstrated leadership capabilities with strong inter-personal communication capabilities
Ability to communicate at all levels of the organization regarding project and business objective status, risks and recommendations/mitigations
Demonstrated knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc)
Systems level product development experience with an appreciation for interactions of the design and risk of components, materials, drugs and manufacturing processes. Inclusive of the interaction of user needs, requirements and how they link to specific test cases and design inputs and outputs.
Excellent knowledge of the philosophy and principles of quality engineering, design verification, design validation, risk management and quality management.
Demonstrated problem solving and decision-making skills.
Strong understanding of failure analysis, test method validation and engineering tolerances.
Broad knowledge of manufacturing operations and quality system practices.
Education and Experience
Must be at least 18 years of age
Bachelor's degree from an accredited college or university is required in Mechanical Engineering, Bio Engineering, Materials Science, Physics required.
8 years of regulated industry experience required, preferably in a quality or compliance position of technical quality assurance experience in a related field
2 - 4 years of management or supervisory experience
Physical Requirements and Work Environment
This is largely a sedentary role.
This job operates in a professional office environment and routinely uses standard office equipment.
While performing the duties of this job, the employee is regularly required to talk or hear
While performing the duties of this job, the employee may be required to sit or stand for long periods of time
Employees are required to use computer
Typically requires travel 20% of the time
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Essential Duties & Responsibilities
Provide effective tactical Quality leadership for Quality Engineers.
Interact and communicate with Senior Leadership across ICU Medical regarding program status, risks, mitigation plans and business objectives
Effectively deploy and assure compliance with ICU Medical's Quality System such as Design Controls, risk analysis/management tools, design verification, design validation, investigations, CA/PA data, etc. to assure product quality
Support design and manufacturing site inspections/audits, representing and defending Design Control compliance for medical device products
Assure systems conform to all applicable US and international regulatory requirements and coordinate development of data and responses for regulators
Understand medical device regulations and assure ICU Medical Quality Systems and documentation remain compliant
Ensure all Quality attributes for design changes and fixes are met. Work with cross-functional teams to coordinate product changes
Provide design quality support, guidance and direction for all manufacturing facilities including driving/managing on-market product issues to closure and escalating to senior management for support as necessary
Define, evaluate, prioritize and correct potential product and process risks to drive continuous quality improvements
Represent the Quality organization as the core team member on Platform/Business teams
Work with on-market teams regarding product life-cycle management and change management
Knowledge, Skills & Qualifications
Demonstrated leadership capabilities with strong inter-personal communication capabilities
Ability to communicate at all levels of the organization regarding project and business objective status, risks and recommendations/mitigations
Demonstrated knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc)
Systems level product development experience with an appreciation for interactions of the design and risk of components, materials, drugs and manufacturing processes. Inclusive of the interaction of user needs, requirements and how they link to specific test cases and design inputs and outputs.
Excellent knowledge of the philosophy and principles of quality engineering, design verification, design validation, risk management and quality management.
Demonstrated problem solving and decision-making skills.
Strong understanding of failure analysis, test method validation and engineering tolerances.
Broad knowledge of manufacturing operations and quality system practices.
Education and Experience
Must be at least 18 years of age
Bachelor's degree from an accredited college or university is required in Mechanical Engineering, Bio Engineering, Materials Science, Physics required.
8 years of regulated industry experience required, preferably in a quality or compliance position of technical quality assurance experience in a related field
2 - 4 years of management or supervisory experience
Physical Requirements and Work Environment
This is largely a sedentary role.
This job operates in a professional office environment and routinely uses standard office equipment.
While performing the duties of this job, the employee is regularly required to talk or hear
While performing the duties of this job, the employee may be required to sit or stand for long periods of time
Employees are required to use computer
Typically requires travel 20% of the time
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