Our Client, a very exciting Medical Device startup, are searching for a Quality Engineer II to join their growing team.Please note: This role is fully onsite with no hybrid or remote working options. Responsibilities include but are not limited to the following:Responsible for compliance with Companies Policies and Procedures and applicable National and International Regulations.Leads compliance and improvement activities associated with the companies quality system (e.g. 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 Companies 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 analyze data to support statistical rational sample testing requirements during early product development and ensure compliance with product specifications, regulations and internal requirementsPrepare and maintain detailed records of inspections, testing, and non-conformance reports.Collect, analyze, 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.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 13485:2016In-depth knowledge of quality engineering principles, methodologies, and tools (e.g., FMEA, SPC, Root Cause Analysis, CAPA, investigations etc.).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, capable of understanding the impact of decision making.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.Note: By applying for this position, you may also be considered by Pale Blue Dot Recruitment for other or future related vacanciesPale Blue Dot® Recruitment - The Resource for the MedTech Workforce