Senior Quality Specialist

Job description

Voted great place to work

Exceptional benefits

Flexible / Hybrid working

Client Details

Our client has consistently been awarded a great place to work, they are extremely committed to employee support and focused on the needs of all whilst maintaining an innovative and high performance culture. We are currently sourcing a Quality specialist for their team, this role will see you playing an integral part in the delivery of their life saving products. A back ground in Pharma or ideally Medical devices will be highly regarded for the role.

Description

Sets the standard and demonstrates a primary commitment to safety and product quality by maintaining compliance with the Quality Policy

Represents the business with regulators, customers and advocacy within the industry.

Acts as quality delegate and provides direction and leadership to the team(s) and business as required.

Develops and champions relationships within Australia, New Zealand, APAC, and the broader global organisation.

Responsible for compliance and leading core areas of Quality Management System (QMS)

Effectively partners and collaborates with commercial and functional teams to develop and influence sound products, processes, and business-related decisions.

Accountable for delivering and leading core quality projects and value improvement (VIP) initiatives that reduce risk, improve efficiency and add value

Leads the business through complexities by applying risk management methodologies to events such as field actions, CAPAs (Corrective and Preventive Action) and all quality related matters

Accountable for representing quality and providing quality direction to the business during change and growth

Profile

8+ years experience in the medical device, healthcare or similar regulated industry

Previous experience in a supervisory, manager role or the ability to demonstrate mentoring / coaching of team members in areas of quality

Bachelors in STEM or a similar related degree

Experience in leading internal audits and / or supplier audits

Experience in facilitating external audits with certifying organisations and / or regulators.

Subject Matter Expertise of regulations and core processes relating to Quality Systems ( CAPA, Nonconforming product / process, Supplier Management, Supply Chain Operations, Regulatory Approvals, Auditing, Post Market, Complaints, Field actions, Customer Feedback / Satisfaction)

High level of communication skills both verbal and written and ability to interpret regulations and quality procedures.

Experience leading projects, continuous improvement initiatives, Value Improvements (VIP) using Project Management and / or Lean / 6-Sigma principles.

Experience in leading a business through nonconforming events and implementation of corrective and preventive actions to mitigate and address risk.

Well-developed people skills and ability to actively engage with stakeholders.

Strong problem solving, organisational and execution skills.

High attention to detail and a collaborative approach.

Job Offer

On offer is an exceptional opportunity to join a highly regarded global business, you will be rewarded with an incredible culture, commitment to your growth and well being as well as learning from some of the best in the industry to support your future career goals.

Please apply through the link in the first instance and long listed candidates will be contacted directly

Lisa Chesterman