Senior Quality Engineer

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Full Remote
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Offer summary

Qualifications:

Bachelor's degree in engineering or science discipline required., Minimum of 4 years of relevant experience in quality engineering or a related field., Experience in a highly regulated medical device environment is preferred., Strong analytical, problem-solving, and communication skills are essential..

Key responsabilities:

  • Develop and maintain quality standards and protocols for product processing.
  • Collaborate with engineering and manufacturing to ensure compliance with quality standards.
  • Lead projects aimed at reducing factory escape risks and improving First Time Quality (FTQ).
  • Consult on quality improvements and manage multiple project work streams.

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Medtronic XLarge http://www.medtronic.com
10001 Employees
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Job description

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

Responsibilities may include the following and other duties may be assigned.

  • Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
  • Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
  • Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
  • Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
  • Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
  • May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
  • Lead projects to drive reduction of factory escape risks at internal and external factories.


Drive elimination of rework or re-processing steps and improvement of value stream stability.

Define, implement and improve First Time Quality (FTQ) program and governance.

Collaborate on the design of new manufacturing lines or equipment that embeds FTQ at the source.

Implement FTQ for the improvement of non-manufacturing, transactional flows.

Partners with management to lead quality initiatives that develop and maintain a high performing, scalable, and compliant Quality System.

Interprets government regulations, agency guidelines, and internal policies to assure compliance.

Partners with Subject Matter Experts to drive development of clear objectives for education packages that improve competency.

Establishes meaningful metrics.

Consults on development of quality improvements and recommends alternatives.

Program management responsibilities may include planning, resourcing, providing status for, resolving issues, and identifying project risks for multiple work streams.

Ensures results meet requirements regarding technical quality, reliability, schedule, and cost.

TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.

DIFFERENTIATING FACTORS

Autonomy: Seasoned individual contributor.

Works independently under limited supervision to determine and develop approach to solutions.

Coaches and reviews the work of lower level specialists; may manage projects / processes.

Organizational Impact: May be responsible for entire projects or processes within job area.

Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties.

Makes improvements of processes, systems or products to enhance performance of the job area.

Analysis provided is in-depth in nature and often provides recommendations on process improvements.

Communication and Influence: Communicates with senior internal and external customers and vendors.

Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.

Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area.

May manage projects, requiring delegation of work and review of others' work product.

Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.

May have practical knowledge of project management.

Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R.

  • 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.


Nice to Have

  •    B.S. in engineering or science discipline. 
  •    3+ years’ experience working in medical device (highly regulated) environment. 
  •    Demonstrated strong business acumen and planning.
  •    1+ years’ experience managing projects.
  •    Demonstrated excellent downward, lateral, and upward communication skills (oral/presentation and written).
  •    Demonstrated strong interpersonal, quantitative analysis, and problem-solving skills.
  •    Demonstrated high degree of initiative and influence management skills.
  •    Demonstrated track record of successfully leading projects to completion.


Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here

Required profile

Experience

Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Quality Assurance
  • Business Acumen
  • Verbal Communication Skills
  • Social Skills
  • Problem Solving
  • Time Management
  • Teamwork
  • Coaching
  • Leadership

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