QA manager I Varsseveld

Microtek Medical B.V. (a division of Ecolab) produces and sells Medical Devices. The Dutch activities consist of sales, warehousing and distribution activities in Zutphen and manufacturing activities in Varsseveld.

For our location in Varsseveld we are hiring a

QA Manager Dutch Operations

The function is to manage and continuously maintain the Quality Management System [QMS] and its linked processes of the Dutch operations of the Healthcare Surgical activities. This is to be performed in accordance with the requirements of the medical devices standard [ISO 13485], the medical device regulation [EU MDR 2017/745], the FDA 21CFR Part 820 requirements and the notified body requirements.

The role of the QA Manager for the Dutch operations is to act as the official Quality Management Representative as per requirements of ISO 13485 clause 5.5.2.

Responsibilities of the role

• The implementation of the Quality Management system in line with ISO 13485 (2016) and the FDA 21CFR Part 820 requirements,
• Prepare and manage the QA department annual budget.
• Support in the preparations and upkeep of the technical files for each product family in line with the EU MDR 2017/745 requirements in quality assurance related tasks. [in coordination with Regulatory Affairs - Europe]
• Support the RA function in the registration process of Medical devices in different countries
• Coordinate and manage the Risk Management activities for the Dutch operations product families.
• Functioning as a member and/or at times as leader of cross functional teams; Leading QA projects in a timely and orderly fashion.
• Leading and supporting the internal audit process to ensure compliance to our quality management systems requirements. [Including actions implementation follow-up]
• Participate and at times lead the investigations on complaints and ensure resolution of quality related issues. Ensure that the complaint management system in Europe is followed and up to date.
• Ensure completion of the monthly Plant scorecard indicators to ensure timely review and communication to the management such as # of complaints, first pass failures, quality costs etc.
• Perform Management review in line with European quality management systems procedures and corporate requirements. [Including actions follow-up]
• Support the continuous improvement process and ensure the training program and processes are in line with our Quality Culture.
• Manage the Quality management system audits conducted by the Notified body and Customers. [Including actions follow-up].
• Support the product development, product modifications. equipment and process validations in the operations. [Including validations protocols write-up].
• Manage the change control process as per European work instruction.
• Ensure that the batch documentation [Production protocols] pertaining to the Varsseveld products are complete, reviewed and signed off for release by the QA Manager and/or assigned trained QA delegates.
• Keep the Microtek Medical [Malta] Limited - QA Manager aware of any deviations, issues encountered on the Malta product whilst in-transit, pre/post sterilization or otherwise.
• Release of DR, GRI and Malta labeled products after successful sterilization process by the QA Manager and/or assigned trained QA delegates.
• Support the supply chain management processes as to avoid back-order situation pertaining to reworks, repack etc.
• Support in the update/creation/approval of product labeling, instruction for use, etc. for the Dutch operations products and/or sub-contractor products under the Medcert number CE 0482 certification.
• Support sub-processes specifically; Clean-room environment control, Bioburden of products, Gamma dose verification quarterly dose audits, etc.
• Escalate any quality issue in house or on the marketplace that need the urgent attention of the EMEA Healthcare Quality Director and/or the European QA Healthcare Surgical Manager. Escalation may include a Product Action Team [PAT] and / or Recall of product.

What specific ‘soft’ skills are required?

• Good leadership skills.
• Good root cause analysis and problem-solving skills.
• Good communication both written & verbal [within the organization and external].
• Good work organization skills combined with follow-up of the assigned tasks until completion.
• Good English writing and communications, preferably also in German

What specific knowledge is required?

• Knowledge and hands-on working experience in ISO 13485 environment.
• Preferably having working knowledge of the Medical devices regulation (EU MDR 2017/745)
• Preferably having working knowledge of the FDA 21 CFR regulations for medical devices.
• Preferably having working knowledge of sterilization and manufacturing process of medical devices.
• Preferably having experience in SAP

Our Commitment to Diversity and Inclusion

Ecolab is committed to fair and equal treatment of associates and applicants and furthering the principles of Equal Opportunity to Employment. Our goal is to fully utilize minority, female, and disabled individuals at all levels of the workforce. We will recruit, hire, promote, transfer and provide opportunities for advancement based on individual qualifications and job performance. In all matters affecting employment, compensation, benefits, working conditions, and opportunities for advancement, Ecolab will not discriminate against any associate or applicant for employment because of race, religion, color, creed, national origin, citizenship status, sex, sexual orientation, gender identity and expressions, genetic information, marital status, age, or disability.