QA Leader

QA Leader

We are currently recruiting for a QA Leader at our Israel office.

The QA Leader will support the Quality Team in maintaining a Quality Management System capable of satisfying the company’s needs. The QA Leader will also Implement systems, procedures and policies to assure compliance with appropriate regulatory requirements.

The QA Leader manages and directs the activities of the quality Assurance operational staff (Internal company and outside company) to ensure that company operations remain in compliance with all supporting systems as per regulations and engineering requirements. Also determines objectives, strategies, systems and procedures for the production line and the warehouse. In addition, monitors compliance and business needs with appropriate departments to ensure operational objectives are met.

The ideal candidate will have proven QA experience and QA education.

Hours of work: 45

Location: Migdal HaEmek

About Sinclair

Founded in 1971, Sinclair is a global medical aesthetics organisation, that delivers an extensive product range. With an in-house commercial infrastructure, including manufacturing and a network of distributors in leading global markets, our products are sold in 55 countries worldwide.

This is a great time to join Sinclair as we continue to increase our product range and expand into new markets and territories.

Our Vision

Providing aesthetic excellence globally.

Our Mission

Driving the advancement of product quality and customer satisfaction, investing in innovation and people.

Our Values

• Act with Integrity
• Be results driven
• Embrace your winning spirit
• Stay ahead of the game
• One team, one goal

Key Responsibilities

• Assist in establishing and maintaining a Quality Management System, capable of meeting applicable regulatory and company requirements including, but not limited to, ISO 13485, MDD/MDR, MDSAP.
• Ensure training is conducted in accordance with agreed timelines and maintain up-to-date personnel training records.
• Process non-conformances and complaints, identifying root cause and implementing appropriate corrective and preventive actions (CAPA).
• Manage the progress of CAPAs and Change Controls ensuring Quality-related aspects are completed in accordance with agreed targets.
• Define and generate all required documentation including engineering protocols, FMEAs, reports, manufacturing instructions, procedures, and SOPs in collaboration with contract manufacturers.
• KPIs follow-up on internal and contract manufacturer processes.
• Assist in the preparation of input slides for Management Review Meetings.
• Participate in internal audits and external audits.
• Collaborate in the management and follow-up of ECOs, from Engineering/R&D to regulatory approval and subsequent implementation in production.
• Ensuring that manufacturing processes comply with the company standards
• Recording, analysing and distributing statistical information
• Specifying quality requirements of raw materials with suppliers

Your Skills & Experience – Do You Have What it Takes?

• Proven QA experience.
• Excellent interpersonal skill with keen eye for detail.
• A problem solver with excellent judgment and analytical skills, confident to work autonomously.
• Hands-on approach, with a “can do” attitude.
• Resilient and proactive.
• Demonstrated competence in using computer programs such as MS Word, Excel and PowerPoint.
• Strong project management and documentation skills.

A bit about you – do you fit this description?

Role competencies:

• Quality assurance education
• At least 2 years of experience in the Quality area or related experience.
• Experience of Quality Management System design and management
• Comprehensive knowledge of ISO 13485 and MDR regulations
• Experience in internal and external auditing.
• Fluent in written and spoken English language.

What We Offer

We have a real focus on developing our people, and by fostering an entrepreneurial culture, we encourage flexibility, accountability and autonomy. The company is full of opportunity for those who wish to grasp it. Our people thrive on engagement, development and a varied workload. You will often be included in projects that require you to collaborate cross-functionally.

This is an exciting opportunity to join a successful company, with big ambitions for the future.

If this sounds like you and you meet the requirements, please apply, we would love to hear from you.

Please note if we receive a high volume of applications, we may close the role before the closing date noted.

By making this application you give consent for personal information to be used in automated decision making processes relating to key job requirements which are stated in this ad.

If you have any questions, please email [email protected].

Sinclair does not accept speculative or unsolicited CVs from Recruitment Agencies. Any unsolicited CVs received will be treated as property of Sinclair and Terms & Conditions associated with the use of such CVs will be considered null and void.