Job Title: Senior Quality Control Inspector
Department: Inspection
Reports To: Quality Control Inspection Supervisor

General Overview of the Role

Reporting to the Inspection Supervisor, this position is responsible for the process inspection of
components, sub-assemble components, finished goods, packing & labels and incoming
materials.

Duties and Responsibilities

Support the Quality Inspection Leader with:

Inspection of raw material, component parts, final devices and packaging to appropriate
AQL levels.
• Performance of inspections in accordance with daily inspection plans.
• Drive inspection process and technique improvements.
• Maintaining good working practices ensuring all measurement equipment is calibrated,
identified and located correctly.
• Ensuring documentation is completed in accordance with good manufacturing practices.
• Use of precision measuring equipment in the measurement of components/products.
• Participation in problem solving activities.
• Identification, containment and documentation of all defective/non-conforming product.
• Raising non-conformances as required on issues arising in inspection such as non-
conforming product or incorrect documentation.
• Following applicable safety and quality policies, and procedures.
• Contributing to the achievement of all quality objectives.
• Participation in improvement activities, such as; continual improvement, corrective action
and customer satisfaction.
• Maintain communication with the Manufacturing Department on current activities.
• Support and deputise for the Quality Control Inspection Supervisor.
• To carry out batch release activities.

Any other duties as assigned by Management

Skills/Experience

• Good organisational skills
• Experience using and programming CMM machine is essential along with experience
using precision measuring equipment. i.e. Vernier’s, shadowgraph etc.
• High and meticulous attention to detail.
• Competent in using Microsoft Windows programs.
• Able to plan, schedule and complete tasks to meet deadlines.
• Experience and knowledge of the Medical Device industry would be advantageous.
• Previous experience in engineering and inspection in a manufacturing environment.
Education

Minimum requirement of at least 4 GCSEs including English and Maths or equivalent.
If you would like to find out more about this role, please forward questions along with your CV to
shazia.chaudhry@surginno.co.uk

NO AGENCIES PLEASE

Job Title: Regulatory Manager
Department: Quality Assurance and Regulatory Affairs Department
Reports To: Group Quality Assurance and Regulatory Affairs Manager

General Overview of the Role

The focus of the role will be to work on the regulatory requirements of the business, especially
by working to meet corporate objectives and contribute to growth of the business. From time to
time, the role may require participation in areas of quality to ensure efficiency of business
activities, continuous improvement and compliance.

Duties and Responsibilities

• Managing global product registrations projects in accordance with country-specific
requirements and internal systems
• Determining regulatory pathways for product registration in various global countries
• Develop and maintain quality management systems for global product registrations
• Determine and maintain regulatory intelligence information and update quality
management systems as required in accordance with this information.
• Updating relevant global, regional and local databases in the product registration
process.
• Organise and maintain reporting schedules for regulatory actions i.e. licence renewals
• Participate in medical device regulatory compliance gap analyses and implementation.
• Managing and assisting with the writing and preparation of technical documentation to
meet regulatory submission requirements e.g. CE submissions and US FDA 510k
submissions.
• Ensuring medical device labelling compliance
• Managing the writing and reviewing of clinical evaluation reports
• Development and management of Post Market Clinical Follow Up (PMCF) projects as
required.
• Distribution - Primary regulatory contact for international distributors, providing support
for enquiries and requests
• Lead and manage distributor evaluation and approval

Management of control of distributors via distributor agreements
Any other duties as assigned by Management

Skills/Experience

• Effective communicator with good interpersonal skills.
• Well organised and able to manage documentation.
• Plans, schedules, and completes tasks/projects to meet deadlines and corporate
objectives.
• Project management skills (work breakdown structure, basic Gantt charting,
communication plan) to manage regulatory projects.
• Commercial awareness.
• Excellent communication and presentation skills.
• Adeptness in multinational regulatory strategy, collaboration with internal and external
stakeholders, key opinion leaders and regulators.
• Customer focused with the ability to develop and maintain good customer relationships.
• Ability to develop and manage a high-performance team.
• Ability to lead, influence and innovate within a cross-functional environment.
• Knowledge/understanding of EU Medical Device Regulations (MDR), FDA regulations
including 21 CFR 820, EU Medical Device Regulations, Canadian Medical Device
Regulations and other international regulations.
• Knowledge and awareness of the requirements of ISO 13485 and ISO 9001
Education

Minimum of a bachelor’s degree required, preferably in a Science or Engineering field.

If you would like to find out more about this role, please forward questions along with your CV to
shazia.chaudhry@surginno.co.uk

NO AGENCIES PLEASE

Job Title: Quality Engineer
Department: Quality
Reports To: Quality Assurance Team Leader

General Overview of the Role

The focus of the role will be to work on the quality system requirements of the business.

Duties and Responsibilities

• Lead on and responsible for NCR/CAPA, root cause analysis investigations.
• Lead on/assist with management of close out of NCR/CAPA actions.
• Support with trend analysis, reporting and presenting of NCR and CAPAs.
• Lead on / assist with company improvement projects.
• Key contact and support for day to day Inspection related issues as required.
• Assisting and supporting with global customer complaints from initial report to completion
and any possible reporting of adverse events to national and international regulatory
authorities as required.
• Carrying out internal audits to ensure compliance.
• Assisting with all environmental monitoring, ensuring it is carried out in a timely fashion
and that records are maintained.
• Support with ensuring routine product sterilisation audit/validation activities are carried
out as required and records are maintained.
• Support with document control activities.
• Participate in compliance gap analyses and creation of action plans for improvement to
the quality system.
• Participate in developing, improving and writing new processes and SOPs as required
• Assist in corresponding with key supplier/customer issues.
• Lead on assigned projects to improve quality/regulatory compliance.
Any other duties as assigned by Management

Skills/Experience

• Effective communicator with good interpersonal skills.
• Customer oriented/focused and able to develop and maintain good customer
relationships.
• Well organised and able to manage documentation.
• Plans, schedules, and completes tasks/projects to meet deadlines and corporate
objectives.
• Able to work in a cross-functional team.
• Good problem-solving ability.
• Commercial awareness.
• Knowledge/understanding of, EU Medical Device Regulation, MDSAP country specific
regulations including, FDA regulations (21 CFR 820), Canadian Medical Device
Regulations and other international regulations.
• Knowledge of the requirements for international quality systems, including ISO 13485
and 9001 required.
• Relevant experience in the Pharmaceuticals/Medical Devices Industry.
Education

Minimum of a bachelor’s degree required, preferably in a Science or Engineering field.
Experience in a Medical Device environment.

Desirable Skills/Education

Internal Audit qualification or certificate

If you would like to find out more about this role, please forward questions along with your CV to
shazia.chaudhry@surginno.co.uk

NO AGENCIES PLEASE

Job Title: Production Engineer
Department: Production
Reports To: Production Manager

General Overview of the Role

The role works alongside the Manufacturing, Quality and Design functions of the business and offers a unique opportunity to implement innovative initiatives to help improve production efficiencies and introduce new products to market.

Duties and Responsibilities

• Produce detailed MVP, PFMEAs & participate in risk assessment activities in accordance with ISO 14971. 
• The validation of manufacturing processes including IQ, OQ and PQ protocols and reports.
• Project management – Ensure NPI projects are transferred into manufacturing on time and to budget.
• Adhere to good documentation practice and actively contribute to maintaining Technical Files, Design History Files (DHRs) and Device Master Records (DMRs).
• Produce DWGs to BS8888 standard.
• 3D CAD modelling and DWG using Pro Engineer/Creo 2
• Run detailed mechanical test programs and produce fully auditable technical reports.
• Assisting with the implementation of corrective actions following customer complaints and both internal and external NCR’s. 
• Constantly reviewing efficiency or cost saving opportunities.
• Support idea generation by defying new processes, problem resolution activities and technology introduction to improve both existing products and aid with new products.

Any other duties as assigned by Management

Skills/Experience

• Must have a professional attitude and flexible approach to working. 
• Be efficient with great attention to detail and commercial awareness of project deadlines.
• The ability to create drawings and CAD files and understanding of component/device modelling along with the understanding of CNC machine/Mould machine programming.
• Proficient knowledge of jig & fixture design and manufacturing. 
• Strong experience of measurement/inspection activities, including GR&R and CMM programming/set up.
• Previous in-depth experience of process validation activities and associated documentation.

Minimum of a bachelor’s degree required, preferably in a Science or Engineering field.
Experience in a Medical Device environment.

Education

Degree or Equivalent in Engineering

Desirable Skills/Education

Medical precision manufacturing background with experience of Injection moulding and machined components.

NO AGENCIES PLEASE