The posting
About Linxens
Linxens is a global leader in micro-connectors, module packaging, antennas & inlays, and secure ID solutions, with over 40 years of innovation. Headquartered in Paris, France, we operate R&D centers and production sites across Germany, France, Sweden, China, India, Singapore and Thailand.
Our solutions serve industries such as telecommunications, finance, transportation, hospitality, e-government, healthcare, and the Internet of Things (IoT).
Our employees’ expertise and know-how allow us to continually reinvent ourselves and meet our customers’ evolving needs, helping them grow and innovate. Therefore, we invest in developing our employees’ skills and career growth.
Working for Linxens means investing in your future. Our growth is creating great opportunities!
Below is the job description for open position
Summary of the position
Implements the SCS quality strategy defined by the BU Quality Manager and in accordance with Group quality directives. He/she may be required to release the production and delivery of medical devices as part of industrialization.
Main missions
Quality Management System Policy (QMS)
Implements systems and procedures ensuring the quality of products and services across all site processes and structures, ensuring that Group quality commitments are respected.
Also ensures that customer needs and specifications are taken into account.
Ensures that Quality System processes are defined, implemented, and maintained in accordance with the requirements of the selected Quality standards. Drives continuous improvement of all these processes.
Reports to Management on QMS performance, notably through the Quality dashboard, and proposes improvement axes.
Ensures compliance of indicators on the shop floor (through audits or other means).
Promotes and raises awareness of the use of appropriate quality tools and methods (PCDA, 5S, 8D, 5M, audit, SPC, Six Sigma, LEAN).
Ensures implementation of corrective and preventive actions.
Participates in Management Reviews, PAC, PEC and Process Reviews.
Audit
Defines the general program for internal and external audits.
Implements tools enabling quality assurance certification (ISO, TS ...).
Communication
Contributes to promoting the QMS policy, raises employee awareness of QMS operation and compliance with its requirements.
Trains teams in the use of quality methods and processes.
Legal monitoring
Controls compliance with and application of legal and regulatory obligations.
Release of medical devices
According to available means, resources, and information, the Site Quality Manager is responsible for releasing production and delivery of medical devices at the Mantes-la-Jolie site during the industrialization phase.
Note: This job description is generic; the responsibilities and duties described are not exhaustive and may evolve according to the company’s operational requirements.
Management and project management
Type of management
- Direct: 5–10
- Indirect: 10–20
- Functional: 5–10
Supervised functions and manager responsibilities
Supervises and evaluates team activity.
Conducts annual reviews.
Ensures downward and upward communication within teams.
Controls compliance with internal procedures to ensure adherence to rules and standards in force within the company and takes necessary actions.
Indirectly manages overall production.
Skills
Technical and functional skills
- Mastery of Quality tools – Six Sigma Black Belt level
- Knowledge of process industries, with data analysis (MES system, etc.)
- Knowledge of quality management systems such as ISO/TS or VDA
- Proven managerial capabilities
- Knowledge in chemistry would be a plus
- ISO 13485 training
Behavioral skills
- Leadership
- Autonomy
- Proactive mindset
- Ability to convince – excellent communication
- Strong ability to deliver results, including in cross-functional work environments
- Strong customer and Operations orientation
Responsibilities
Leads analysis and control of safety risks within his/her scope.
Implements necessary preventive actions to reduce these risks.
Ensures compliance with safety procedures and instructions in force.
Member of the Site Management Committee.
Ensures product quality by limiting internal PPM and customer complaints.
Ensures compliance with ISO 9001, ISO 14001, ISO 13485 requirements.
Authorized to stop production or delivery of products that do not comply with quality commitments defined between Linxens and its customers, or to refuse validation of deliverables lists or before APQP phase gate (before project review).
This responsibility particularly applies to medical devices in accordance with ISO 13485.
Specific aspects of the function
Main internal contacts
Mechanical Engineering Manager & overall vision, HR Director, Financial Controller, UAP Manager, Logistics Manager, Operations Quality Manager, HSE & Maintenance Manager, Lean Manager, Purchasing Manager, Production Quality.
Leads and motivates quality department technicians and engineers (development, suppliers, customers, system, metrology), ensures alignment of department resources (headcount and competency level) with operational needs.
Recruits.
Trains and develops required competency levels.
Main external contacts
Customers, Suppliers, Auditors
Performance indicators
- Number of customer complaints
- Internal PPM
- Customer scoring
- Number of audits completed
Other
Executive standby duty
Requirements
Education / Degrees
Master’s degree (BAC +5) or engineering degree in quality
Experience
Proven experience in operational Quality management of 5 to 10 years.
Experience in a highly customer-demanding industry is required.
Experience in the medical device field (ISO 13485 certified company) would be a plus.
Languages
French: Native English: Professional proficiency
Join Linxens to work in a multicultural environment, collaborating with leading tech innovators and making a global impact on technology.
LINXENS is an equal-opportunity employer that strictly prohibits unlawful or unethical discrimination. Moreover, as part of our CSR Vitality program, we have committed to recruit, hire, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity, national origin, age, mental/physical disability, marital status, or any other characteristic protected by law.
