Company Description medmix is a global leader in high-precision delivery devices. We occupy leading positions in the healthcare, consumer, and industrial end-markets. Our customers benefit from our dedication to innovation and technological advancement that has resulted in over 900 active patents. Our 14 production sites worldwide, together with our highly motivated and experienced team of nearly 2’700 employees provide our customers with uncompromising quality, proximity, and agility. medmix is headquartered in Baar, Switzerland. Our shares are traded on the SIX Swiss Exchange (SIX: MEDX).
Quality & Industry - Head of Quality for Industry Business Unit
The Head of Quality for Industry Business Unit (BU) is responsible for overseeing and managing all aspects of quality control and assurance to ensure that products and services meet or exceed customer expectations. They are responsible to ensure that all Industry manufacturing sites and design control centers are compliant to the relevant ISO standards and are able to interact with the appropriate regulatory bodies. They ensure customer complaints are handled in a compliant and timely manner with robust root cause investigation and corrective action. This role requires strong customer focus, leadership skills, a deep understanding of quality management systems, and the ability to drive continuous improvement initiatives.
Responsibilities
* Quality Management Systems: Develop, implement, and maintain an effective quality management system (QMS) that aligns with industry standards and regulatory requirements. Establish processes and procedures for complaint handling, quality control, document control, corrective and preventive actions, and continuous improvement. Scope of the role includes oversight of quality responsibilities across Industry manufacturing processes in our sites in Valencia, Shanghai, Hungerford, Haag and Atlanta.
* Quality Control: Develop and implement quality control processes and procedures to ensure that products and services consistently meet quality standards. Establish inspection and testing protocols, monitor product quality throughout the production or service delivery process, and address any non-conformities.
* Supplier Quality Management: Collaborate with procurement and supply chain teams to establish and maintain strong supplier quality management processes. Conduct supplier audits, evaluate supplier performance, and implement measures to ensure that suppliers meet quality standards.
* Quality Assurance: Develop and implement quality assurance strategies and processes to prevent defects and ensure compliance with customer requirements. Define quality metrics and KPIs, conduct root cause analysis for quality issues, and implement corrective and preventive actions.
* Continuous Improvement: Drive a culture of continuous improvement throughout the organization. Lead initiatives to enhance quality processes, optimize efficiency, and reduce waste. Utilize quality tools and methodologies, such as Six Sigma and Lean, to identify improvement opportunities and drive their implementation.
* Customer Satisfaction: Monitor customer feedback and satisfaction levels to identify areas for improvement. Collaborate with cross-functional teams to address customer complaints, implement corrective actions, and ensure that customer requirements are met.
* Ensures robust and efficient change control processes in the industry business.
* Training and Development: Provide training and guidance to employees on quality standards, procedures, and best practices. Foster a culture of quality awareness and provide resources to enable employees to fulfill their quality-related responsibilities.
* Compliance: Stay up to date with relevant industry standards, regulations, and certifications. Ensure that the organization complies with applicable quality and regulatory requirements. Coordinate audits and certifications, address findings, and implement necessary actions for compliance.
* Leadership and Team Management: Provide leadership and guidance to the quality team. Foster a collaborative and high-performing team environment. Set performance goals, conduct performance evaluations, and mentor team members to promote their professional growth and development.
Qualifications
* Bachelor's degree in Industrial Engineering, Operations Management, or a related field (Master's degree preferred)
* Proven experience in quality management roles (multi-site responsibility or global scope)
* In-depth knowledge of quality management principles, methodologies, and tools (e.g., Six Sigma, Lean)
* In-depth knowledge of relevant quality standards (e.g., ISO 9001) and industry-specific regulations
* Strong analytical and problem-solving skills
* Excellent communication and interpersonal skills
* Ability to lead and influence cross-functional teams
* Detail-oriented with a focus on continuous improvement
* Strong organizational and project management skills
* Languages: Spanish, English - Business Fluent
Additional Information
* medmix is an equal opportunity employer, committed to the strength of a diverse workforce.
* 93% of our employees would go above and beyond to deliver results – do you have the drive to succeed? Join us and boost your career, starting today!
Quality & Regulatory Manager (SGS)
We are SGS – the world\'s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.
At SGS, we have an open corporate and international culture. We offer a dynamic work environment in a leading global company. Our high professional standards and our sustainability approach guarantee you a future-oriented work environment. We invest in our employees for the long term and are committed to supporting your development within the company. Our business principles include: Integrity, Health, Safety & Environment, Quality & Professionalism, Respect, Sustainability, and Leadership.
Main Purpose of Role To centrally manage a Lean and compliant Quality Management system for medical devices schemes (Medical includes Notified Body NB1639, UKCA, ISO 13485, MDSAP and all other Medical Schemes at SGS)
* Management of external audits and communication with competent authority
* Management of internal audits and communication with relevant departments
* Maintaining designation under MDR/IVDR and support the development and designation under new schemes
* Maintaining accreditation under MDSAP, ISO 13485 and UKCA and support the development of other new schemes
* Coordinate all activities with auditing organisations (Belgian and English competent authority, UKAS)
* Coordinate all complaints and regulatory request (CEF) to provide customers and CA appropriate answers
* This role will report to the Head of Certification and Compliance, Business Assurance.
It is remote based, and we are open to candidates located everywhere across Europe. But they must hold a valid work permit for their country of residency.
Key Accountabilities
* Own and oversee all medical devices processes, including the Quality Manual, Non-Conformity and CAPA handling, audits and inspections, document and records control, internal audits, quality management reviews, concessions, and impartiality.
* Supervise the implementation and maintenance of the medical quality management system (QMS), ensuring alignment with global processes and accreditation requirements.
* Ensure impartiality and independence from commercial interests, including conducting annual risk analyses.
* Maintain QMS regulatory compliance to support designation and accreditation under MDR/IVDR, ISO 13485, MDSAP, and other relevant schemes.
* Lead internal and external audits and ensure timely closure of CAPAs.
* Conduct the annual Quality Management Review and ensure timely follow-up and closure of actions.
* Write and revise QA-related procedures and associated documentation.
* Continuously optimise the QMS to improve turnaround times while maintaining compliance.
* Make decisions related to the Notified Body QMS and proactively drive continuous improvement initiatives.
* Compile and analyse data for management review reporting.
* Manage all regulatory processes to ensure full compliance across all Medical Schemes.
* Ensure all contractual agreements, including those with inter-office and subcontractors, are current, compliant, and properly maintained.
* Responsible for updating the Quality Management System (QMS) and informing relevant medical personnel in response to changes in standardisation activities, applicable legislation, guidance, and best practices.
* Plan and implement relevant regulatory training programs in collaboration with training team.
* Ensure the SGS Medical website remains current and accurate in terms of regulatory content.
* Build strong working relationships with global medical device teams and proactively work on projects with stakeholders
* Provide technical support and training across the business, when required
* Manage and develop the Quality & regulatory team, including performance management, coaching, and staff development.
Skills & Knowledge
* Strong knowledge of Medical Device Regulations (MDD, MDR, IVDR) and ISO13485, ISO17021 and MDSAP
* Strong ability to work with senior management, technical, marketing, sales, and administrative personnel at a corporate, regional and delivering office level
* Ability to represent SGS to medical device regulatory authorities and other external fora
* Excellent interpersonal and communication skills including fluency in English
* Negotiation and persuasion skills
* Change Management skills
* Strong organisational skills and flexibility
* 5+ years’ experience in Quality Assurance or Regulatory assurance on a global or multi-site scale gained in a Notified Body organization (a must have).
* 2+ year experience in team management (must have)
* Has at least 10 years’ experience of either working in a Health Science related industry in Design, Manufacturing or Quality and Regulatory functions, or previous experience with either Management System registrars, Notified Bodies or Testing laboratories or Industry
* Has a keen eye for detail and is focused on delivering results within agreed timeframes
* Operates ethically with the highest degree of professional integrity
Qualifications
* Essential: Higher education qualification (Masters / Ph.D. / B.Sc. (Hons) Degree) in a relevant life / natural sciences subject.
* Completed Medical device training on MDD, MDR, IVDR, UKCA, MDSAP and ISO 13485
* Please send your CV in English
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 continuous 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.
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