Quality Engineer II

I am partnering with an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease (ICAD) are looking to hire a Quality Engineer II as they expand operations.

The Role :

This position requires experienced and proven track record in Quality and Regulatory control of medical devices. This role will focus on ensuring product quality during early development phases through to commercial. Development and supporting Quality Management System (QMS) activities, batch release, internal audits, and supplier management.

Responsibilities :

Responsible for compliance with Policies and Procedures and applicable National and International Regulations.

Leads compliance and improvement activities associated with the quality system (. CAPA, audit programs, personnel training).

Apply thorough, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Plan, execute, report and follow-up on quality system audits. Act as an audit escort and / or support in the coordination of backroom activity during inspections as required.

Provide expertise in the areas of quality assurance, controls and systems to support and develop the QMS.

Develop and implement control plans, inspection plans, and testing strategies to ensure product compliance with design and regulatory requirements.

Work closely with suppliers to ensure robust quality agreements are in place, including periodic review of their quality metrics.

Provide ongoing support to the internal teams in the development of products, through first article inspection qualifications, and test method development and approval activities through to commercial.

Gather and analyse data to support statistical rational sample testing requirements during early product development and ensure compliance with product specifications, regulations and internal requirements

Prepare and maintain detailed records of inspections, testing, and non-conformance reports.

Collect, analyse, and report key data related to product testing, supplier performance, and internal quality metrics.

Use data-driven insights to drive continuous improvement initiatives, ensuring optimal product quality and process efficiency.

Develop test protocols or reports to support the design validations and verification activities.

Support the quality control activities, relating to lot release of finished devices, received products or other QC activities.

Review and approval of changes to product, processes for existing medical device products are conducted in compliance with global regulations and internal procedures.

Requirements :

A degree in quality engineering, life science or related field.

3-5 years experience at a quality assurance role in the medical device sector essential, preferably in a FDA / MDR regulated environment.

Quality certification and lead Auditor certification an advantage.

Knowledge of FDA’s 21 CFR Part 820 (Quality System Regulation) and ISO 13485 : 2016

In-depth knowledge of quality engineering principles, methodologies, and tools (., FMEA, SPC, Root Cause Analysis, CAPA, investigations .

Experience in the QA activities associated with the design and development of medical devices.

Results and deadline driven with an ability to handle multiple tasks and operate in a fast-paced environment.

Excellent interpersonal skills and ability to work with people to achieve results.

Excellent written and communication skills, fluency in English, attention to detail and strong technical writing skills.

Proven record of policy and procedure development.

Good judgment / decision making and problem-solving ability,

Highly motivated with excellent communication skills and proven ability to work effectively as part of a team an interact professionally with all organizational levels.

Proficiency in MS office products.

Good business acumen and an enthusiastic self-starter.