Senior Quality Engineer

Join to apply for the
Senior Quality Engineer - Evening Shift
role at
Medtronic
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all.
You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
At Medtronic, we value what makes you unique.
Be part of a company that thinks differently to solve problems, make progress and deliver meaningful innovations.
Our Purpose
At our Quality Department in Medtronic, plc, we focus on supporting the product value stream to ensure that customer and patient needs are met every day.
Our key focus is on delivering and maintaining a high level of Quality to ensure that business and performance goals are achieved.
The Senior Quality Engineer role is critical in supporting key department metrics by contributing to the global strategy and to deliver on our mission to contribute to human welfare by supporting the manufacture of products that alleviate pain, restore health, and extend life.
In our Structural Heart Post-Market Quality Department, we focus on partnering with internal and external colleagues to plan and execute Post-Market strategies for continuous improvement of products, methodologies, processes, and departmental interfaces, while working within the organisation to build, motivate and lead high performance teams.
Come for a job, stay for a career
A Day in the life of:
Responsibilities may include the following and other duties may be assigned.
Apply knowledge of design control principles and quality engineering techniques throughout the product development process and the product lifecycle.
Lead and manage the receive inspection function ensuring incoming materials and components meet defined specifications and regulatory requirements.
Lead root cause analysis and resolution of non-conformances related to incoming material.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Provide input to design and manufacturing deliverables including material specifications, drawings, inspection procedures to ensure that the resulting products can be adequately manufactured and tested.
Understand risk management concepts used throughout the quality system to successfully meet FDA, ANSI/AAMI/ISO 14971:2019, and ANSI/AAMI/ISO 13485:2016 requirements.
Lead cross-functional teams including issue triages for CAPAs or Hazard Analysis, etc.
As necessary, proposes changes in design or formulation to improve system and/or process reliability.
Supporting internal and external audits (MDR/MDSAP/FDA etc).
Key Skills & Experience
Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
Requires a minimum Level 8 degree in Engineering or other relevant discipline with minimum 4 years' relevant experience or advanced degree with minimum 2 years of relevant experience.
Must have practical knowledge of project management.
Experience in a highly regulated industry, preferably medical devices.
Experience with solving complex issues by interacting with cross functional groups.
Proven ability to operate in a matrix organisation and navigate complex business systems, regulations, standards, and performance requirements.
Knowledge of reliability tools and practices that effectively support requirements, design, integration and verification, and validation.
Demonstrated critical thinking skills with focus on improved system performance outcomes and positive business impact.
Excellent communication and ability to influence is critical to the role.
Ability to work independently to plan and schedule own activities necessary to meet timelines.
Medtronic Offer a Competitive Salary And Flexible Benefits Package
Equal Employment Opportunity
Medtronic is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, sex, age, national origin, disability, sexual orientation, marital status, veteran status, or any other protected status.
#J-18808-Ljbffr