Design Quality Engineer II

2 weeks ago

Perth, Western Australia Smith & Nephew Full time

Design Quality Engineer II page is loaded

Design Quality Engineer II Apply locations PRT - Coimbra time type Full time posted on Posted 3 Days Ago job requisition id R76388

Life Unlimited . At Smith+Nephew we design and manufacture technology that takes the limits off living.

This position will be based in Coimbra (Hybrid role) and will be reporting to Design and Quality Engineering Manager.

The Design Quality Engineer is responsible for implementing, supporting, and sustaining elements of Smith and Nephew's quality system. Under the guidance and direction of the Quality Engineering Manager, they ensures that medical device regulations, standards, and guidelines are aligned with through execution of Smith and Nephew procedures.

What will you be doing?

  • Analyze post market surveillance data, identify trends and verify products are performing within established risk profiles. Prepares and presents results of analysis to Sports Medicine leadership in Post Market Surveillance Trend Review meetings.
  • Perform routine updates of product risk management files per Smith and Nephew procedures.
  • Support compliance and process improvement initiatives related to Operations, Engineering, and Quality functions (e.g. product quality, product transfers, complaints, labeling, validation, automation of systems, etc.).
  • Lead the review, disposition, and correction/corrective action activities associated with discrepant components, materials, sub-assemblies, and finished products.
  • Assist in the preparation and coordination of Internal and External audits to International and US standards and quality policies and procedures.
  • Establish and maintain successful multi-functional relations with Materials, R&D, Engineering, Manufacturing, Marketing, IT, Finance, Sales, Quality, and Regulatory Affairs departments. Coordinate corrective actions for issuance, review and closure of action plans.

Responsibilities:

  • Generate/approve/manage post market surveillance and risk management activities.
  • Ensure compliance to product specific standards, cGMP, QSR, US FDA, ISO, IEC, UL, EN, MDD, and EU MDR requirements. Ensure that all the responsibilities within the scope of this job comply with the scope of the Quality System.
  • Provide quality oversight and leadership for quality related issues (e.g. non-conforming material, corrections, deviations, CAPA, etc.). Investigates, documents and leads corrective/preventive actions to assure these are managed effectively.
  • Provide quality support to product support project teams as the quality engineering representative. Work with a team to develop methods and procedures to ensure that the appropriate tests are conducted to assure that products meet the required specifications/standards and that the safety and reliability of products are established. Generate/approve/manage design verifications, design validations, sterilization validations, process validations, supplier qualifications, test methods, capability studies, and risk management documentation.
  • Support Management Review, and internal and external audits/inspections.
  • Assist in other responsibilities requested by management to ensure compliance.

What will you need to be successful?

Bachelor's degree in science, engineering, or other related field

2 years minimum experience in the medical device or related industry.

Portuguese and English proficient

Competencies:

  • Need to be able to make sound decisions with attention to details
  • Understanding the impact of regulatory requirements (e.g. GMP's, ISO 13485, ISO 14971, MDD, EU MDR, etc.) on Smith & Nephew's products is necessary
  • Must be able to provide and implement solutions to quality problems
  • Ability to plan and schedule multiple projects and tasks
  • Effective written/oral communication skills
  • Team player
  • MS Office, MS Excel, and Statistical software proficiency

Travel Requirements:

Up to 5% domestic

You. Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

  • Inclusion, Diversity and Equity:Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about our Employee Inclusion Groups on our website ( )
  • Your Future:Generous annual bonus, Save As You Earn share options.
  • Work/Life Balance:Meal allowance, Health insurenace, Flexible Vacation and Time Off, Paid Holidays and Paid Volunteering Hours, so we can give back to our communities
  • Flexibility:Hybrid Working Model (For most professional roles).
  • Training:Hands-On, Team-Customised, Mentorship.
Applications:

If you share our passion for pioneering innovation and can demonstrate how you meet the criteria outlined, we would love to hear from you.

We continue to actively build an environment where every individual can fulfil their potential and be proud ambassadors for Smith & Nephew, our customers and their patients.

We value the diversity of our people and welcome applications from everyone.

#li – ar2

#LI-Hybrid

Stay connected and receive alerts for jobs like this by joining our talent community .

We're more than just a company - we're a community Follow us on LinkedIn to see how we support and empower our employees and patients every day.

Check our Glassdoor page for a glimpse behind the scenes and a sneak peek into You . Unlimited . , life, culture, and benefits at S+N.

Explore our new website and learn more about our mission, our team, and the opportunities we offer.

About Us

165 years of pioneering innovation requires a relentless focus on what's next. We're focused on you. You're what's next...Ready to take your career to the next level? Join our talent community for access to new job opportunities. Sign up now

#J-18808-Ljbffr

  • Electrical Engineer Level II

    2 weeks ago

    Perth, Western Australia Airswift Full time

    Electrical Engineer Level IIResponsible for driving and delivering safe and sustainable 'fit for purpose' electrical engineering services for the Resources Portfolio group. You may be working on multiple projects dependent on their size across various Resource clients.Our client are also delivering projects focused on enablement of future green energy and...

  • Electrical Engineer Level II

    2 weeks ago

    Perth, Western Australia Airswift Full time

    Electrical Engineer Level IIResponsible for driving and delivering safe and sustainable 'fit for purpose' electrical engineering services for the Resources Portfolio group. You may be working on multiple projects dependent on their size across various Resource clients. Our client are also delivering projects focused on enablement of future green energy and...

  • Electrical Engineer Level II

    2 weeks ago

    Perth, Western Australia Airswift Full time

    Location Perth, Western Australia, Australia Job Type Contract Date Added April 30, 2024 Electrical Engineer Level II Responsible for driving and delivering safe and sustainable 'fit for purpose' electrical engineering services for the Resources Portfolio group. You may be working on multiple projects dependent on their size across various Resource...

  • Electrical Engineer Level Ii

    2 weeks ago

    Perth, Western Australia Airswift Full time

    Electrical Engineer Level IIResponsible for driving and delivering safe and sustainable 'fit for purpose' electrical engineering services for the Resources Portfolio group.You may be working on multiple projects dependent on their size across various Resource clients.Our client are also delivering projects focused on enablement of future green energy and...

  • Electrical Engineer Level Ii

    2 weeks ago

    Perth, Western Australia Airswift Full time

    Electrical Engineer Level IIResponsible for driving and delivering safe and sustainable 'fit for purpose' electrical engineering services for the Resources Portfolio group.You may be working on multiple projects dependent on their size across various Resource clients.Our client are also delivering projects focused on enablement of future green energy and...

  • Electrical Designer Level I/ii

    2 weeks ago

    Perth, Western Australia Origin Resources Australia Pty Ltd Full time

    Great opportunity to grow and learn skills Fulltime & immediate start Work across multiple sitesABOUT USOrigin Resources are a proudly Indigenous owned company that provides quality and reliable recruitment and labour hire services.Our client is at the forefront of the Energy & Resources industryTHE OPPORTUNITYOur highly reputable client is looking for a...

  • Electrical Engineer

    2 weeks ago

    Perth, Western Australia Quality People Full time

    Job Title:Electrical Engineer Location:Canberra Duration:12 months + Contract Responsibilities: Designing, developing, and testing electrical equipment and systems Participating in the planning and execution of complex maritime projects Skills and Experience Required: Tertiary Qualifications in Electrical Engineering Provide planning advice and guidance on...

  • Electrical Engineer

    2 weeks ago

    Perth, Western Australia Quality People Full time

    Job Title:Exciting Opportunity for an Electrical EngineerCompany:Join our innovative team in CanberraDuration:12 months + ContractResponsibilities:- Designing, developing, and testing innovative electrical equipment and systems- Participating in the planning and execution of challenging maritime projectsSkills and Experience Required:- Tertiary...

  • Electrical Engineer Level II

    2 weeks ago

    Perth, Western Australia Knewin Full time

    About the job We are seeking an Experienced Electrical Engineer to join our team in Perth. When you become part of our team, you become part of a community of nearly 50,000 individuals united by a shared goal – contributing to a more sustainable world. We are enthusiastic about the opportunities that lie ahead. In our opinion, there has never been a better...

  • Electrical Design Engineer

    2 weeks ago

    Perth, Western Australia Australia Wide Full time

    around $90 per hour plus super depending on experienceinner western Sydney locationtrue technical design role for experienced electrical design engineerAre you looking for a 6 to 12 month contract electrical design engineer role? Our partner, who is a leading global provider of mission critical air and gas handling products for the mining industry, is...

  • Electrical Design Engineer

    2 weeks ago

    Perth, Western Australia Australia Wide Full time

    Around $90 per hour plus super depending on experienceinner western Sydney locationtrue technical design role for experienced electrical design engineer Are you looking for a 6 to 12 month contract electrical design engineer role? Our partner, who is a leading global provider of mission critical air and gas handling products for the mining industry, is...

  • Civil Engineer Level II

    2 weeks ago

    Perth, Western Australia Airswift Full time

    Job OverviewAirswift is presently seeking an accomplished Civil Engineer to join our client on an initial 12-month contract at one of their facilities in Perth, CBD.Your extensive experience in civil engineering and collaboration with diverse teams across multiple office locations will be invaluable in completing this crucial project, which plays a key role...

  • Senior Engineer

    2 weeks ago

    Perth, Western Australia Design and Build Recruitment Full time

    Job DescriptionJoin a dynamic and global team of over 11,000 talented professionals spread across more than 60 countries. As a key player in the organization, you will be part of an agile network that fosters collaboration, connection, and growth on a global scale. Embrace the chance to unleash your potential, learn, create, and develop alongside some of the...

  • Civil Engineer Level II

    2 weeks ago

    Perth, Western Australia Airswift Full time

    Location Perth, Western Australia, Australia Job Type Contract Date Added May 3, 2024 Job Overview Airswift is presently seeking an accomplished Civil Engineer to join our client on an initial 12-month contract at one of their facilities in Perth, CBD. Your extensive experience in civil engineering and collaboration with diverse teams across multiple...

  • Senior Mechanical Design Engineer

    2 weeks ago

    Perth, Western Australia Breville USA, Inc. Full time

    About Breville Over the past 90+ years Breville has grown to become an iconic global brand, deliveringkitchen products to over 70 countries around the globe.Breville enhancespeople's lives through the delivery of brilliant innovation and thoughtfuldesign based on deep consumer insights, empowering people to do things moreimpressively or easily than they'd...

  • Senior Mechanical Design Engineer

    2 weeks ago

    Perth, Western Australia Breville USA, Inc. Full time

    About BrevilleOver the past 90+ years Breville has grown to become an iconic global brand, deliveringkitchen products to over 70 countries around the globe. Breville enhancespeople's lives through the delivery of brilliant innovation and thoughtfuldesign based on deep consumer insights, empowering people to do things moreimpressively or easily than they'd...

  • Senior Design Engineer

    2 weeks ago

    Perth, Western Australia Robert Bosch Group Full time

    As a leading specialist in drive and control technology, Bosch Rexroth manufactures products and systems that are associated with the control and motion of industrial and mobile equipment and ensures efficient, powerful and safe movement in machines and systems of any size. It offers its customers Industrial hydraulics, Mobile hydraulics & Electronics, Gear...

  • Senior Design Engineer

    2 weeks ago

    Perth, Western Australia Robert Bosch Group Full time

    As a leading specialist in drive and control technology, Bosch Rexroth manufactures products and systems that are associated with the control and motion of industrial and mobile equipment and ensures efficient, powerful and safe movement in machines and systems of any size.It offers its customers Industrial hydraulics, Mobile hydraulics & Electronics, Gear...

  • Structural Engineer Level II

    2 weeks ago

    Perth, Western Australia Airswift Full time

    Job OverviewAirswift is presently seeking an accomplished Senior Structural Engineer to join our client on a 12-month contract at one of their facilities in Perth, CBD.Your extensive experience in structural engineering and collaboration with diverse teams across multiple office locations will be invaluable in completing this crucial project, which plays a...

  • Electrical Design Engineer

    2 weeks ago

    Perth, Western Australia Monford Group Full time

    About Monford Group Built "from the ground up" and led by a hands-on management team, Monford's success stems from its integrity, quality and streamlined processes.Monford is a leader in the construction industry, with an Australia-wide portfolio of projects in the Infrastructure, Resources and Energy sectors.Whether for construction only, Design and...