Current jobs related to Senior Quality Engineer - Macquarie Park New South Wales - Saluda Medical

  • Senior Project Engineer

    1 hour ago

    Macquarie Park, New South Wales, Australia Freyssinet Australia Pty Ltd Full time $120,000 - $180,000 per year

    Senior Project Engineer – Remedial DivisionLocation: Sydney, New South WalesDivision: RemedialEmployment Type: Full-timeFreyssinet Australia is seeking a driven and experienced Senior Project Engineer to join our Remedial Division, delivering complex and technically challenging remediation and façade upgrade projects across NSW. This is a fantastic...

  • Senior Coal Quality and Logistics Engineer

    2 weeks ago

    Mudgee, New South Wales, Australia Peabody Energy Full time US$90,000 - US$120,000 per year

    We are seeking a driven and experiencedSenior Coal Quality and Logistics Engineerto join our team at the Wilpinjong Mine – a large-scale open-cut operation located 40km northeast of Mudgee. Producing high-quality thermal coal for both domestic and export markets, Wilpinjong plays a critical role in our wider operations.This is an outstanding opportunity...

  • Senior ETL Developer, Data Engineer

    2 weeks ago

    Macquarie Park, New South Wales, Australia DXC Technology Full time US$90,000 - US$120,000 per year

    Job DescriptionSenior ETL Developer, Data EngineerDXC Technology (NYSE: DXC) helps global companies run their mission-critical systems and operations while modernizing IT, optimizing data architectures, and ensuring security and scalability across public, private and hybrid clouds. The world's largest companies and public sector organizations trust DXC to...

  • Junior Network Engineer

    4 days ago

    Macquarie Park, New South Wales, Australia xceltium Full time $60,000 - $90,000 per year

    You've put in the hard work. You've earned your CCNA, you've built solid hands-on experience over the past 1–2 years, and you've proven yourself in troubleshooting and support. But now you're ready for more.You don't just want to reset passwords or monitor dashboards, you want exposure to enterprise environments, client projects, and cutting-edge...

  • Senior Project Engineer

    2 weeks ago

    Orange, New South Wales, Australia Pivot Engineers Full time $120,000 - $180,000 per year

    Company DescriptionPivot Engineers is a engineering consultancy based in Melbourne, we have grown our portfolio of projects and clients significantly over the past few years with our team supporting many Major Infrastructure Projects, Private Mining Clients and Subcontractors.Role DescriptionThis is a contract FIFO role (14/9 roster) on-site role located in...

  • Senior Project Engineer

    2 weeks ago

    Albury, New South Wales, Australia Martinus Full time $104,000 - $130,878 per year

    Delivering one of the countrys biggest rail infrastructure projectsFIFO-2/1 all flights, travel, accommodation plus 20% uplift on salaryWork for 100% Australian owned company offering genuine career progression.The CompanyMartinus is a 100% Australian owned and operated rail construction company working on some of Australia's largest rail infrastructure...

  • Senior Estimator

    4 hours ago

    Macquarie Park, New South Wales, Australia Freyssinet Australia Full time $120,000 - $180,000 per year

    Senior Estimator – Major Projects DivisionLead the Future of Remedial Estimating at Freyssinet AustraliaFreyssinet Australia is expanding We're building a newly createdMajor Projects Division, and this is your opportunity to take the lead as aSenior Estimator. In this role, you'll spearhead estimating for high-value remedial projects, playing a key role in...

  • Quality Engineering Intern

    2 weeks ago

    Liverpool, New South Wales, Australia Prysmian Full time $60,000 - $80,000 per year

    Who We ArePrysmian Group is the largest global cable manufacturer, with over 100 years of experience and knowledge of making cables. With a strong focus on our three core values, Drive, Trust & Simplicity, we are committed to creating a diverse and inclusive workforce and encourage all suitably qualified applicants to apply.We work to be the sustainable link...

  • Systems Engineer

    2 weeks ago

    Macquarie Park, New South Wales, Australia Raytheon Australia Full time $90,000 - $120,000 per year

    Date Posted:Country:AustraliaLocation:AUSNSW121: Macquarie Park NSW, Level 3 Building D Talavera Corporate Centre, 12-24 Talavera Road, Macquarie Park, NSW, 2113, AustraliaPosition Role Type:UnspecifiedFast track your career on breakthrough defence projectsGain hands-on experience from concept to delivery.Learn from the best in a high calibre team with great...

  • Senior Quality Assurance Engineer

    3 weeks ago

    Parramatta Park, Queensland, Australia NSW Department of Customer Service Full time

    Join to apply for the Senior Quality Assurance Engineer role at NSW Department of Customer ServiceJoin to apply for the Senior Quality Assurance Engineer role at NSW Department of Customer ServiceGet AI-powered advice on this job and more exclusive features.NSW Department of Customer Service provided pay rangeThis range is provided by NSW Department of...

Senior Quality Engineer

2 weeks ago

Macquarie Park New South Wales, Australia Saluda Medical Full time $90,000 - $120,000 per year

About Saluda Medical
Founded in 2013, Saluda Medical is dedicated to transforming patients' lives with disruptive neuromodulation solutions. As leaders in the field, we have achieved exceptional pain management results through more than a decade of advanced research, development, and clinical experience. We are a global healthcare company redefining Spinal Cord Stimulation (SCS) therapy at the intersection of automated algorithms, real-time diagnostics, and groundbreaking clinical evidence. Our advanced neuromodulation systems for the next generation of implantable stimulation devices are distinguished by Dose-Control Technology via measurement of physiological response.

What We're Looking For...

Working with a team of engineers and Quality Control Inspectors as our Senior Quality Engineer & QC Supervisor you will be responsible for ensuring the appropriate quality controls, improvements, and production related quality system are effectively implemented in the manufacturing facilities. You will also be responsible for ensuring the products are manufactured in accordance with applicable regulatory requirements, controlled QMS procedures and work instructions, customer expectations, and industry standards.

Your role will include:

  • Mentor Quality Engineering team on compliance and improvements related issues.
  • Supervise and support Quality Control Inspectors, facilitating prioritisation of QC tasks.
  • Monitor and maintain the Saluda Quality Management System (QMS) to ensure compliance to ISO 13485 and applicable regulatory requirements.
  • Ensure all requirements of QMS related to Receiving, Goods Inwards, Production and Distribution are planned for and implemented withing the QMS.
  • Support DHR, DMR and DHF compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained.
  • Liaise across business functions to ensure the product design/development teams and manufacturing operations translate design requirements into manufacturing requirements during design transfer to increase manufacturability, reduce scrap and improve operational efficiencies.
  • As needed, collaborate with product development team to ensure Design for Manufacturing has been considered in New Product Introduction.
  • Ensure QMS is implemented in full, with records maintained to support compliance to both local and international regulatory requirements, whilst maintaining an audit ready status.
  • Supporting non-conformance process, providing standards and direction, leading corrective and preventative activities.
  • Ensure prompt investigation and action and escalate quality issues based on appropriate analysis.
  • Initiate NCR and CAPA investigation and take actions as required including driving required changes to completion.
  • Assist management in implementing the company policy and company objectives. Ensure records are maintained to allow measurement against them.
  • Participate in internal audits to ensure company's quality system is effective.
  • Assist development and maintenance of Manufacturing Quality Plans for quality control to ensure manufacturing process and product conformance.
  • Continually assess the end-to-end process to ensure efficient, effective, predictable, and timely quality control activities and provide metrics for Data Analysis and Management Review.
  • Analyse data to identify trends in product quality or defects with a goal of mitigating and preventing recurrence and future defects.
  • Identifies root causes of problems in the production process; recommends and/or implements corrective measures.

About you:

  • A bachelor's degree or higher in Materials Science, Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or related Engineering discipline.
  • 6-10 years' experience in Medical Device Manufacturing environment.
  • Critical thinker with High-level analytical and problem-solving skills
  • Communicate effectively, drive execution, foster innovation, focus on the customer, collaborate with others, solve problems creatively and demonstrate high integrity.
  • Proven self-starter/able to take initiative, detailed oriented.
  • Advanced written and verbal communication skills and ability to produce reports & presentations to a professional standard.
  • Effective time-management, interpersonal and analytical skills.
  • A proven ability to successfully lead and mentor people.
  • Ability to implement quality and regulatory procedures to meet organisational objectives.
  • Ability to maintain professional internal and external relationships.
  • Knowledge of medical device regulatory requirements. An understanding of the requirements of ISO 13485:2016 and/or 21CFR 820
  • Knowledge of Risk management requirements (ISO14971).

It's not essential, but nice if you have:

  • Product lifecycle management system development
  • Project Management
  • People management experience

At Saluda, we challenge boundaries. We innovate and think beyond the conventional. We disrupt.

Are you Ready to Join? If you would like to be part of our team developing the world's next generation of implantable device technology, contribute to making an impact on patient care, then this is the opportunity for you Please APPLY NOW

Applications will only be considered from candidates with the appropriate approval to work in Australia, no visa or sponsorship is available for this role.
All eligible candidates are invited to apply. We respectfully ask for no agency approaches.