ENGINEER II - QUALITY ASSURANCE ENGINEERING

Pioneering trusted medical solutions to improve the lives we touch.
Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care.
With around colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring.
Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs.
Convatec’s revenues in were over $2 billion.
The company is a constituent of the FTSE 100 Index (LSE.
TEC).
To learn more about Convatec, please visit http://www.
onvatecgroup.
om Purpose of the function/position.
Have a position responsible for.
The inspections and the adequate planning and documentation.
Notify and follow up on problems found in processes, products and materials.
Analysis on documentation of the area to be updated in accordance of planned changes/projects.
Responsibilities.
System.
To assist to Senior Quality Control Engineer in the implementation of the requirements into the QA System to ISO Standard & FDA CGMP Quality System Regulation.
To assist in to carry out internal audits when this is required.
To provide or assist in Quality Assurance Training programs.
To follow up all work instructions and quality records.
To provide collections and keeping of quality records of the area.
To comply with the company quality policy Leadership & Inspections.
To supervise the activities of the Quality Inspectors / QC lider.
To evaluate the necessary resources to perform the task inspections and release the material in a correct way meet with the deliveries on time (resources, equipment, etc.).
To evaluate that the established systems are running in a right way.
To evaluate the plans of inspection and test method from the processes in order to improve them or simplify f apply.
Assure that the Q.
.
personnel have the proper training to perform the activities of the area.
Responsible of the coordination of personnel for the adequate planning on the product inspections also on participation on special activities as the reworks/reinspection, validation process tests, product and process changes, special records, measurements, investigations, etc.
if this is required.
Disposition of material/products.
Responsible of control of the materials in detention in the quarantine of the clean room.
Responsible for the follow up and final disposition of subassemblies and final product (no conformance, acceptable materials, etc.) in adequate time.
Support to Supplier Quality Supervisor on the raw material disposition, when is required.
Support to Process Quality Engineer for monitoring or failure analysis, when is required.
Release of final products.
Responsible for the release of final product that fulfill with quality specifications and adequate records in accordance with the Quality System.
Coordinate and communication with support areas (logistic, production, etc.) to release products in time and adequate documentation without affect delivery to the customer.
Responsible for product release for subassembly sent to DK is according to quality specifications and records according to quality system.
Notify quality to suppliers.
Communication with Supplier Quality Supervisor and/or suppliers in order the services can be improved, assuring the approval of them through the documented information requested by our system, if required.
Notify to Supplier Quality Supervisor and/or suppliers according with procedures about the quality problems on supplied materials.
To Coordinate in Mexico the communication meeting with Denmark to discuss and follow the quality problems regarding to materials and processes.
Non-Conformities on process.
Support the quality system on adequate handling of non-conformity activities.
Coordinate the investigation with the team member involved (maintenance, production, logistic, engineering, etc.) when is needed Collect and review the objective evidence to complete the investigation and therefore the correct NC closure when is needed.
Issue a NC/CAPA when needed according to procedure established.
Participate on review board meetings, when required.
Lead the NCRB meeting, when required.
Others.
Active participation on projects that are been assigned as consequence of implementation of process and/or product changes.
Participate on root cause analysis, plans for corrective/preventive actions, analysis of FMEA's, if required.
Safety, Health, and Environment Responsibilities.
Comply with safety, health and environmental policy, procedures established by the EHSMS.
Maintain applicable documented information related to the EHSMS up to date.
Participate in committees, trainings, and awareness, to ensure proper competency of their position if applicable. Be aware of and support compliance with applicable significant environmental aspects and associated significant environmental impacts.
Understand EHS risk and legal requirements relating to job responsibilities and appropriate requirements.
Execute job responsibilities with professional care and in compliance with legal requirements and internal standards without compromising the safety of self and others.
Be alert to EHS hazards in the workplace, responding to them as appropriate and communicating them to responsible management as soon as they are identified (e.
.
spills).
Help drive continuous performance improvement in EHS areas, recommending potential improvements to responsible management.
Participate in identifying opportunities for improvement and implementing the necessary actions to achieve the intended results of their activities.
Powers.
To use QA System to make constant improvements in products, processes and systems to reduce cost of failures and meet customer requirements.
To take corrective/preventive actions to deviation.
To stop machinery operation, activities or processes that can affect the quality of the product or quality system.
Requirements.
Job profile.
Bachelor degree, required (industrial area or similars) 2 year of experience as supervisor / personnel handling English required (verbal and written, intermidate level) Software utilization skills / Computer skills Auditor skills preferred Measurement equipment knowledge skill preferred Molding process knowledge preferred Familiar/knowledge of basic requirements of FDA QSR's GMP's and ISO or similar regulations, preferred.
#LI-Hybrid #LI-AR2 Beware of scams online or from individuals claiming to represent Convatec A formal recruitment process is required for all our opportunities prior to any offer of employment.
This will include an interview confirmed by an official Convatec email address.
If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever.
If you’re unsure, please contact us at .
Equal opportunities Convatec provides equal employment opportunities for all current employees and applicants for employment.
This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting.
Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec.
No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
Thank you.
Already a Convatec employee? If you are an active employee at Convatec, please do not apply here.
Go to the Career Worklet on your Workday home page and View \"Convatec Internal Career Site - Find Jobs\".
Thank you! Convatec ist im Wandel.
Wir sind dabei, unser Geschäftsmodell umzugestalten, angetrieben von der Entschlossenheit, das Leben von Millionen von Kunden auf der ganzen Welt zu verbessern.
Unser gemeinsamer Fokus und die schiere Tatkraft unserer Mitarbeiter verleihen uns eine echte Eigendynamik.
Unsere Mitarbeiter machen uns auch zu einem einzigartigen, belebenden Arbeitsplatz.
Kommen Sie zu uns.
Egal welche Rolle Sie spielen, Sie werden jeden Tag gefordert und gefördert.
Sie werden auch unterstützt und dazu befähigt, dort, wo es am wichtigsten ist, Veränderungen anzustoßen und voranzutreiben.
Wir haben ein einzigartig dynamisches, manchmal anspruchsvolles Umfeld.
Aber wenn Sie motiviert sind und sich genauso wie wir darauf konzentrieren, das Beste für die Patienten zu erreichen, wird dies das Beste aus Ihnen herausholen.
Sie werden nie stillstehen.
Und Sie erzielen vielleicht auch die größte Veränderung in Ihrer gesamten Karriere.
Wenn Sie wissen möchten, wie wir Ihre Daten nach Ihrer Bewerbung verwenden, lesen Sie bitte unsere vollständige Datenschutzerklärung unter dem folgenden Link.
https://www.
onvatecgroup.
om/privacy-policy/