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Senior Qa Specialist (12 Month Contract)

Leica Biosystems - Mount Waverley, VIC

Source: uWorkin

Source: uWorkin


Who We Are

At Leica Biosystems our promise is to enable clinicians to efficiently provide patients a highly confident diagnosis within 24 hours of biopsy. We offer the most comprehensive portfolio that spans the entire cancer diagnosis workflow from biopsy to diagnosis. Our experts are committed to delivering Improved Quality, Integrated Solutions, and Optimized Efficiencies leading to breakthrough advances in diagnostic confidence and turnaround time.

Every day we embrace new ways of thinking and work closely together to deliver innovative technologies, to ensure we remain at the forefront of our industry. And we believe that our people around the world play the most important role in helping our customers find success.

The Role

This is a temporary professional position with responsibilities for elements of the site quality system with particular focus on Design Quality. The Senior Quality Assurance Specialist is experienced in multiple areas of medical device quality assurance and is capable of applying that experience and in-depth knowledge to work independently with minimal guidance from management. Serves as a resource for colleagues with less experience. May lead small projects with manageable risks and resource requirements. Ability to solve complex problems affecting the quality system. Shares information and experience across LBS and Danaher sites; may serve as representative on taskforces, councils or improvement initiatives.

Your key responsibilities will include, and not limited to:

  • Premarket QA / Design Assurance / R&D Quality
    • Critical review of documents to be included in the design history file for IVD devices.
    • Conduct internal audits of design control projects.
    • QA representative for Design Controls and Risk Management for new product development projects and device change initiatives.
    • Support design quality assurance for cross-site projects.
  • May also include support of one or more of the following Quality System areas:
    • Establish and maintain quality system to meet all applicable requirements for medical device/IVD business, e.g. 21 CFR 820, ISO 13485 and EU IVDR.
    • Internal and external audits
    • CAPA
    • Validation
    • Customer Complaint and Adverse Event Investigations
    • Batch release
    • Training
    • Record management and document control
  • Utilize knowledge and experience to identify, solve and document problems and risks within the quality system.
  • Serve as a resource and mentor to colleagues with less experience, including QA Officers.
  • Use Danaher Business System (DBS) tools on a regular basis to continually improve the QA function.
  • Work closely with RA/QA management in developing quality objectives.
  • Establish and maintain strong relationships with internal and external stakeholders.
  • Maintain working knowledge of relevant regulations and quality system requirements that affect the business.
  • Other duties as assigned by management.

To be successful in this opportunity, a prior experience in the following criteria would be required:
  • Bachelor’s degree preferably in science, medical or engineering.
  • Minimum 5 years Quality Assurance experience in medical device quality systems required, IVD instrument experience highly desirable.
  • Demonstrated experience in:
    • Design Control and risk management for new product development and product lifecycle.
    • Conducting and hosting quality system audits.
  • Proven cross-site, cross-functional business partnering.
  • Ability to identify, analyze and mitigate risk (e.g. product, material, compliance, supply)
  • Critical thinking.
  • Attention to detail.
  • Ability to work independently.
  • Strong organizational skills. Ability to multitask.
  • Strong communication skills (verbal/written/presentation/relationship building) with ability to work collaboratively with cross-functional project teams.
  • High level of initiative, self-motivation and energy.
  • Ability to explain difficult or sensitive information. Works to build consensus.
  • High level of integrity. Consistently uses sound judgment. Operates with transparency and is trusted. Demonstrates humility and self-awareness.

To Apply:

You must be an Australian citizen or a holder of a Permanent Residency visa to be eligible to apply for this position.

This is an exciting opportunity to be a part of Leica Biosystems and its ongoing success. So if you want a career where you can use your deep expertise to deliver real results, talk to us first.

Please apply for this position by submitting your confidential application online.

Applicants must submit a cover letter explaining their interest in joining Leica Biosystems and relevant experience related to this role. Applications must be submitted by close of business 23rd April 2021.

Leica Biosystems is committed to attracting and retaining the most highly qualified candidates available. We firmly believe that our employees drive the success of the company. With success in mind as the ultimate goal, we strive to create and provide an environment that offers challenging, stimulating and financially rewarding opportunities. If you are seeking a new challenge where your performance and contribution is valued, and the role aligns with your next career move, we would love to hear from you.

Be sure to follow Leica Biosystems on LinkedIn!

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.