Sr. Manager, Quality Engineering/Design Assurance

Introduction

This position ensures new product development Quality Engineers and their associated project teams utilise appropriate engineering and scientific analyses and processes during product development.

Important

Sr. Manager, Quality Engineering/Design Assurance

The Job

Job Title
Sr. Manager, Quality Engineering

FLSA Status
Exempt

Position Summary
This position ensures new product development Quality Engineers and their associated project teams utilise appropriate engineering and scientific analyses and processes during the product development/qualification and commercialisation process for our Clients products. 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 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 our Clients 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 our clients Quality System such as Design Controls, risk analysis/management tools, design validation, design verification, investigations, CA/PA data, etc. to assure product quality
• Support 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 our Clients 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 corporate 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, prioritise and correct potential product and process risks to drive continuous quality improvements
• Represent the Quality organisation as the core team member on Platform/Business teams
• Work with on-market teams regarding product life-cycle management and change management

Essential Qualities/Key background:

• Medical Device background and quality systems experience required
• Previous managerial experience required with strong leadership and communication skills
• Design Control and Risk Management background
• CAPA experience
• Engineering education and background
• Self-directed leader, especially given supervisor will be off site in the United States

Knowledge, Skills & Qualifications

• Demonstrated leadership capabilities with strong inter-personal communication capabilities
• Ability to communicate at all levels of the organisation 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 components, materials, drugs and manufacturing processes
• Excellent knowledge of the philosophy and principles of quality engineering 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

• Bachelor's degree from an accredited college or university is required in Mechanical Engineering, Bio Engineering, Materials Science, Physics
• 10+ of years of experience

Minimum Qualifications

• Must be at least 18 years of age
• Must pass pre-employment drug screen and background check

Travel Requirements

• Typically requires travel 20% of the time

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.

Physical Requirements and Work Environment

• Work is performed in a clean room environment
• While performing the duties of this job, the employee may be required to sit or stand for long periods of time; depending on the machine they are operating
• Operator is required to use computer or touch screen to enter work order data
• Must be able to occasionally move and lift objects of up to 25 lbs

We are an Equal Employment Opportunity Employer, Female/Minority/Veterans/Disabled/Sexual Orientation/Gender Identity.