Sr Quality Engineer

Job Description

SENIOR DESIGN QUALITY ENGINEER Careers that Change LivesHelp streamline and speed our time to market and build quality in at every step. You will be a member of the new product development quality team that supports the design and development of innovative, new products within the Renal Care Solutions business. You can apply design controls concepts from product ideation through commercialization.Impact patient outcomes. Come for a job, stay for a career. A Day in the LifeTo provide quality engineering support in the design and development of innovative products for Renal Care Solutions through design controls planning, test method development, verification and validation. The individual shall support cross-functional development project teams and collaborate with other Medtronic and external engineering groups to ensure that new products and product changes are adequately evaluated/tested with respect to requirements and product Design History File is complete. Responsibilities Include:

• Evaluates product design and identifies potential design quality issues and drive technical decisions
• Works within a development team to identify and implement effective controls to support the development, qualification, and commercialization of products to meet or exceed internal and external requirements.
• Assists on-time completion of Design Control Deliverables
• Accountable for ensuring Design Verification and Validation execution and deliverables comply with quality system regulations and internal requirements
• Prepares risk management files and report for product releases, and has responsibility for active participation in risk management activities from product conception through commercialization
• Supports design test and inspection method development and validation
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Ensures DHF and DMR content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
• Supports and ensures the establishment of objective, measurable, discrete, and verifiable customer and product requirements
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
• Supports in the development and maintenance of Quality Management System procedures
• Support audits, CAPA/NCR/SCAR investigations and reports
• Perform other related duties as assigned

Must Have: Minimum Qualifications

• 5-7 years of experience with a Bachelor s Degree in a technical/engineering discipline; or
• 3-5 years of experience with a Master s Degree in a technical/engineering discipline; or
• Medical or Pharmaceutical industry experience

Nice to Have

• Experience designing and testing medical device preferred
• Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance
• Good statistical data analysis skills
• Design for Six Sigma and Critical to Quality training and experience a plus
• Ability to manage multiple projects across multiple geographies.
• Excellent verbal and written skills
• Able to work independently, as well as in a team environment
• Experience with 21CFR820, ISO13485, and ISO14971
• Customer focused and service oriented
• Ability to educate stakeholders, customers and management
• Ability to interface with internal customers, suppliers and regulatory agencies
• Experienced working with cross-functional and international teams
• Knowledge of FDA and TUV requirements.
• ASQ certification a plus
• Travel up to 20-30%

About MedtronicTogether, 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 team. Let s work together to address universal healthcare needs and improve patients lives. Help us shape the future.Additional Information

• Posting Date: Jan 4, 2021
• Travel: No

,

Keyskills :
inspectionqualityquality controlisocalibrationnew product developmentstatistical data analysisverificationvalidationquality management systemstatements of work sow