Manufacturing Quality Engineer

Company Description

Inspiration Healthcare is a British based, global provider of medical technology, and our mission is to pioneer medical technology that improves outcomes of patients, starting with the very first breaths of life.

We provide high-quality, innovative products to patients around the world that help to improve patient outcomes, and we actively invest in innovative product opportunities, disruptive technologies and, of course, our people.

The Group currently consists of three companies: Inspiration Healthcare Ltd, SLE Ltd and Viomedex Ltd and, under these brands, we sell neonatal intensive care and operating theatre equipment around the world through a network of distributors into over 75 countries.

We also offer a full range of ambulatory infusion care devices for both hospital and homecare applications to customers across the UK and Ireland.

Products range from highly sophisticated capital equipment through to single-use disposables all of which can help improve outcomes of extremely sick patients.

We can proudly admit that we haven't come this far without entrepreneurial spirit, a solution driven attitude, and a determination to improve outcomes for premature and sick babies. So if making a positive difference to other people's lives resonates with you and you believe that you have what it takes to flourish and succeed in this role, then we’d love to hear from you.

Position

Job Purpose (Role Definition):

The Manufacturing Quality Engineer is responsible for:

§ ensuring the implementation of process and their compliance to ISO 13485 and MDSAP;

§fordeveloping,implementing,andmaintainingqualityassuranceprocessesandsupportingthe

ManufacturingQualityTeam LeadonthepromotionandawarenessofQuality;

§ is responsible for supporting the ManufacturingQualityTeam Lead on quality complianceculturewithin theGroupensuringthatallstaffareawareoftheCompanies’Quality Management System processesandthe need to adhere to them.

Main Duties and Responsibilities:

• Support the promotion of quality awareness of applicable quality requirements and Business Management System requirements throughout the Group;
• Ensure compliance to all applicable quality standards, regulations and internal procedures by proactively interpreting Quality requirements, and devising and implementing solutions to support the maintenance and enhancement of the Business Management System quality documentation;
• Reviewing non-conformance (ventilator components – mainly electronic boards) products on RED ZONE team meetings reported in Malfunctions (Priority System) and register them in Track Wise System;
• Conducting investigation of production problems (mainly electronics components) to identify, root causes, corrective actions and deliver preventative measures.
• Provide analysis and trends of nonconformities reported from production and support the Manufacturing Quality Team to implement preventative measures for identified trends.
• Provide support to Research and Development with NPI/project based activities;
• Ensure quality processes needed for the Business Management System within the Group are documented in accordance with Medical Device Single Audit Program (MDSAP), Medical Device Directive (MDD) and Medical Device Regulation (MDR);
• Conduct calibration and verification activities of measurement assets, and maintain calibration records.
• Conduct maintenance activity for R&D assets;
• Conduct internal and external audits per the audit schedule;
• Support Quality Control processes;
• Support Supplier Quality Assurance team (SQA);
• Liaise with other Quality Assurance and Regulatory Affairs team members to present Quality issues that may affect the Group;
• Travel to all sites may be required.

Management Responsibilities:

None

Requirements

Experience and Qualifications Required:

Mandatory:

• Previous experience in a quality assurance role in a medical device organisation;
• Previous experience in electronics role;
• Root Cause Analysis;
• A demonstrable knowledge in ISO13485.

Desirable:

• Expert knowledge in continuous improvement activities and problem solving techniques;
• ISO13485 Internal Lead Auditor;
• Awareness of Medical Device Directive and Medical Device Regulation.

Key Skills and Competencies:

• A demonstrable and broad understanding of medical device manufacturing quality assurance;
• The ability to interpret quality requirements to ensure that implications for users and processes are clear;
• The ability to learn quickly and establish a high degree of product quality knowledge and expertise in different markets;
• The ability to engage and deliver compelling presentations to a varied audience, and communicate and present a technical subject matter in an understandable, coherent manner;
• The ability to engage, inspire and manage subordinate staff to achieve the same levels of excellence expected of yourself;
• Excellent communication skills, flexible attitude and capable of multi-tasking and working to tight deadlines under pressure;
• Excellent presentation skills with the ability to analyse and present data in a cohesive way;
• The ability to get on with and to influence people both internally and externally to achieve objectives;
• Clear thinker who can work independently and show leadership in managing and undertaking activities.

Other information

As well as being dedicated to providing a great place to work in a rewarding, stimulating and environmentally conscientious environment, we offer an extensive range of benefits, listed below, and actively support learning and development opportunities for all:

• 25 days' holiday pa, rising to 28, plus bank holidays
• Blended working options
• Enhanced pension scheme (with salary sacrifice option)
• Bonus schemes
• Sharesave scheme
• Mind & body wellbeing support
• Healthcare cash plan
• Retailer discounts
• Life assurance
• Enhanced and equal leave & pay for new parents
• Cycle to Work
• SmartTech scheme
• Electric Car Benefit
• Employee referral scheme
• Travel season ticket loan