Senior Quality Engineer

A Senior Quality Engineer is required by CareerWise Recruitment for our client. The Senior Quality Engineer is responsible for Design Assurance and Quality Engineering support for Medical Devices products. This role shall support the Quality Engineering Manager for Quality Assurance & Quality Control activities related to Development, Manufacturing, Release & Testing of Medical Device products in Compliance Applicable Device & Drug Regulations and standards. Supports the Development and Implementation of required procedures, documentation, inspections, instructions, protocols/reports in compliance with applicable requirements to ensure Company products adhere to established specifications and industry quality standards. In addition, this role may lead or support Quality responsibilities such as Post-Market Surveillance, CAPAs, NCMRs, and Complaints. REMOTE/HYBRID opportunity

Role of this position

• Provide Quality Engineering support in successful transition from development and clinical production activities to commercial manufacturing using design and manufacturability concepts, including statistical techniques.
• Assist in the development and implementation of validation and inspection methods to analyze and assure product quality based on sound statistics.
• Assist in quality engineering activities at contract manufacturing organizations (CMO) from receiving to final release, including but not limited to, training, validation, and continuous monitoring of product/process performance.
• Supports Quality oversight of drug substance and drug product CMOs as well as analytical laboratories, as needed.
• Performs disposition of batch production records, supports the conduct of internal and supplier quality audits and proactively manages issues and risks to company goals and objectives.
• Participates in audit readiness activities for mock audits, FDA pre-approval inspection and commercial launch of the drug product.
• Manage and conduct root cause investigations and corrective actions for nonconformances for quality issues, product design, and manufacturing & testing processes at contract manufacturing organizations.
• Responsible for working with R&D and Operations including supplier monitoring and audits, risk management and internal controls while ensuring compliance with ISO 13485, 21 CFR 820, 4, 210, 211, and other applicable standards and regulations pertaining to Company products.
• Collaborate with Regulatory Affairs and cross functional teams to ensure appropriate execution of development and validation strategies and preparation of risk assessments as needed.
• Review and approve method validations, change control, CAPA, deviations and investigations, in collaboration with CMOs.
• Assist business partners to ensure that process development, manufacturing, scale up and project timelines are consistently met per corporate objectives.
• Contribute to the successful execution of departmental and company goals.
• Regularly update and recommend to Company stakeholders the status of objectives, projects, and goals, particularly how they relate to cross-functional business objectives.
• Assist in technology transfer to partner or contract manufacturing organizations, as applicable.
• Support and/or lead activities related to the Post-Market Surveillance program, compiling data across departments to develop PMS plans and reports.
• Promote and support a quality and continuous improvement culture.
• Other miscellaneous projects/activities as assigned.
• This position does not have direct supervisory responsibilities.

JOB REQUIREMENTS

• Bachelor's Degree in Engineering or related technical specialty.
• Quality Engineering related professional certification a plus.
• 6+ years of experience in design/manufacturing quality engineering in the medical device industry (catheter experience preferred). Familiarity with drug-device combination products and/or drug products a plus.
• Experience in planning and conducting product and process activities in compliance with FDA 21 CFR 820, MDD, MDR, ISO 13485 & 14971 and other applicable regulatory requirements.
• Provided Quality oversight and guidance for cross-functional technical projects pertaining to the device product.
• Experience with writing/editing/reviewing effective procedures and technical documents.
• Experience with development, clinical, and commercial product release activities.
• Experience with root cause investigations and corrective actions.
• Experience in the oversight and management of contract manufacturing organizations.
• Experience with Post-Market Surveillance plans and reports. KNOWLEDGE:
• Working knowledge of device product quality and regulatory requirements, including but not limited to the requirements outlined in 21 CFR 820, MDD, MDR, ISO 13485 & 14971.
• Knowledge of US/EMA/MHRA and applicable ICH guidelines for drug substance and drug product, including but not limited to the requirements outlined in 21 CFR 4, 210, 211, and ICH guidelines.
• Well-versed in best practices for Design Assurance, product/process Risk Management, Statistical techniques, and Post-Market Surveillance.
• Understanding and application of risk management and validation methodologies.
• Working knowledge of electronic quality management systems for documentation, change control and training.
• Familiarity with one or more types of Quality System Software's used in the industry.

SKILLS:

• Excellent organization, communication (written and verbal), and interpersonal skills.
• Positive mindset, flexibility, and the ability to build cooperative working relationships with internal and external stakeholders in a start-up environment.
• Ability to learn fast and work successfully within a team/collaborative environment, with a high level of professionalism and sense of urgency to produce high quality outputs within given timeframes.
• Critical thinking and problem-solving abilities to propose practical and achievable solutions.
• Detail orientation with the ability to detect and correct errors and/or inconsistencies in documentation.
• Proficient in MiniTab (or equivalent statistical software) and Microsoft Office applications e.g. Outlook, Word, Excel, Visio, PowerPoint, and Teams.

PHYSICAL DEMANDS & CONDITIONS

JOB REQUIREMENTS

• This position is based in Ireland and may be remote home-office based or company office based, depending on where the incumbent resides.
• It requires up to approximately 20-25% travel which may include, but is not limited to, supplier visits/audits, applicable conference/seminar attendance, regulatory audits/inspections, and internal meetings.

Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.