Global Technical Manager – Sterilization

The role is fully remote and reports to the Head of Delivery & Operations

Main Purpose of Role

• Oversee sterilization processes within medical devices and provide technical support related to sterilization across all certification schemes - MDR MDD UK MDR ISO13485 MDSAP IVDR.
• Act as line manager and lead the team of MDR Product Assessors-Sterilization.
• Provide technical advice in relation to sterilization to support all stages of the medical device conformity assessment process
• Establish competence criteria update deliver and maintain appropriate training packages for Product Assessors (sterilization team) as well as sterilization auditors covering all certification schemes related to sterilization within the medical device conformity assessment process.
• Develop maintain and implement sterilization QMS documentation related to medical devices conformity assessment process of SGS NB 1639 aligned with best practices (e.g. NBOGs BPG MDCG guidance documents) and applicable regulatory and accreditation requirements.
• Manage the development and implementation including approval process for Product Assessors (sterilization team) and sterilization auditors new personnel and for on-going monitoring and re-approval of personnel.

In addition to above as member of the Global Operations Leadership Team:

• Accountable for resource management within the team reporting to the role including workload planning capacity monitoring and proactive identification and resolution of resource gaps including Hubs and DO resources.
• Drive team performance against global targets with full accountability for chargeability utilisation productivity timeliness assessment quality and regulatory compliance including Hubs and DO resources.
• Lead proactive decisionmaking ensuring operational and technical issues are resolved at the appropriate level with minimal escalations and delays.
• Act as a primary technical reference point within the area of responsibility providing clear and consistent guidance to the team Delivering Offices (DOs) and Hubs ensuring aligned interpretation of regulatory requirements and internal procedures.
• Establish a culture of accountability and performance by setting clear expectations defining individual and team goals and monitoring delivery against operational and technical objectives.
• Monitor analyse and report team performance implementing timely corrective actions and providing regular updates to the Head of Operations.
• Drive continuous improvement by identifying and implementing process efficiencies capability development initiatives and best practices within the team.
• Contribute to business growth including supporting proposals client interactions training and external engagements as required.
  

Key Accountabilities Sterilization

• Maintain a full knowledge and understanding of SGS (Global System and SGS NB 1639) procedures Best Practices Guides MDCG Guidance Documents and external approval criteria to allow efficient and effective technical reviews. Ensure full compliance with the Companys Code of Integrity Secrecy and Non-Disclosure Agreement and act in accordance with SGS policies procedures and processes.
• Ensure regulatory compliance of medical device technical documentation assessments under applicable regulations and schemes
• Be a point of contact regarding queries relevant to sterilisation and support CE marking activities carried out by SGS including support of clients complaints support of delivering offices.
• Provide training and qualification support in relation to sterilization across the SGS NB 1639 conformity assessment process including recruitment assessment approval and ongoing capability.
• Initiate and support process improvements activities as needed.
• Develop external training packages for clients by providing regulatory advice and guidance within the scope of notified body. Undertake personal professional development and ensure appropriate training records and personal logs are updated to maintain relevant knowledge.
• At all times adopt a safe behaviour by exercising due regard for the health and safety of yourself colleagues and clients in line with the Companys policies and procedures.
• Oversee competence management activities including the authorization of codes(qualification) monitoring and reapproval of personnel
• Monitor team KPIs (chargeability utilization productivity timeliness assessment quality) and support corrective actions when required.
• Perform an annual appraisal for existing team members and an appraisal after three (3) and six (6) months for new team members. Implementation of the performance management and disciplinary process as required.
• Support the achievement of medical devices operational and financial targets.

In addition to that as member of the Global Operations Leadership Team additional responsibilities as below:

• Act as the senior technical authority for the assigned scope ensuring consistent interpretation and application of regulatory and internal requirements.
• Provide expert technical support to team members DOs and Hubs including resolution of complex technical issues and escalations.
• Lead the development maintenance and implementation of technical procedures guidance documents and training materials.
• Support business development activities by providing technical input for proposals client interactions and external events.

Skills & Knowledge

• Good working knowledge of medical device management systems medical device compliance and auditing and technical documentation assessment techniques.
• Effective interpersonal skills able to develop good working relationships with medical device teams and delivering office colleagues.
• Appropriate knowledge and understanding of devices legislation as well as harmonised standards CS and guidance documents in regards to sterilization.
• Appropriate knowledge and understanding of the conformity assessment procedures provided for in the regulations for medical devices.
• Knowledge and experience with the NBs quality management system related procedures and the required qualification criteria.
• The ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
• Experience of management of cross functional global teams is an asset.
  

Experience

Essential

• More than 10 years in the Medical device industry (at least 5 years within sterile medical device research and development and/or manufacturing) including experience in design control or manufacturing and sterilization processes (microbial monitoring packaging integrity as well as sterilization validations) of devices but as well in QMS auditing and/or technical documentation assessment covering sterilization.
• 5 years as a MDR and/or IVDR medical device Lead Auditor / Product Assessor Sterilization within a Notified Body.
• 2 years of experience in a leadership role. Demonstrated experience in technical decisionmaking and expertlevel problemsolving.
• Experience in competence management training or qualification of technical personnel.
• Experience supporting or leading global or crossfunctional teams.

Desirable

• Experience working under own initiative and in planning and prioritising work.
• Experience of management of cross functional global teams is an asset.
• Good overall understanding of SGS processess and quality management system.
• Previous experience in a Notified Body or equivalent regulatory environment.
• Experience in developing technical procedures or training programmes.

Qualifications :

• Successful completion of a university or a technical college degree or equivalent qualifications in relevant studies such as microbiology but can be medicine pharmacy engineering or relevant sciences with microbiology modules.
• Technical Manager Sterilization candidate must be or have previous been a qualified as a MDR Product Assessor and/or as MDR Lead Auditor.
• Previous medical device training (e.g. Product Specific; Standards Specific (sterilization standards ISO 13485 ISO 14971); Directive Specific (93/42/EEC 98/79/EC) Regulation (EU) 2017/745).

Additional Information :

Why SGS

• Global and very stable company world leader in the TIC (Testing Inspection and Certification) industry.
• Flexible schedule and hybrid model.
• SGS university and Campus for continuos learning options.
• Multinational environment where you will work with colleagues from multiple continents.
• Benefits platform.

Join Us: At SGS we believe in innovation collaboration and continuous improvement. We offer a supportive and inclusive work environment that encourages professional growth and personal development.

Remote Work :

Yes

Employment Type :

Full-time

Experience: years
Vacancy: 1