Quality Assurance Analyst Jobs

Sinclair are currently recruiting for a QA Analyst at their Irvine office in California on a temporary contract. The QA Analyst will be required tasks to support and maintain the Quality Management System for a medical device company in compliance with appropriate regulatory agencies and regulations to include but not limited to ISO Standards, cGMP's, FDA regulations and company policies and procedures.

Hours of work: 20-30 hours a week

Location: 18 Technology Drive, Suite 134, Irvine, CA, 92618

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

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

Key responsibilities

• Review all product complaints & ensure timely reporting of those events to regulatory agencies as necessary. Generate monthly summaries as requested.
• Maintain customer complaint, Non-Conformance and Corrective and Preventive Action system per procedures.
• Perform all required training and maintain records.
• Assist in 3rd party external audits of the QMS by Notified Bodies, Registrars and Competent Authorities.
• Interfacing with internal teams and/or contract manufacturer effectively resolving conflicts and achieving objectives related to the product or raw material.
• Assist contract manufacturer with investigations and material review board (MRB) activities to determine disposition, determine re-inspection requirements, CAPAs, and approve to close.
• Generate and maintain monthly trends and analysis of key quality indicators as it relates to the QMS.

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

Essential :

• Bachelor of Science/Engineering with at least 2-4 years of experience in the Quality area or related experience
• Full understanding of requirements & implementation of Quality Systems compliant with US & international requirements for medical device manufacturers.
• Quality management experience within the medical device industry is preferred.

Desirable :

• Experience in internal and external auditing.
• Experience in cGMP, 21 CFR 820, ISO 13485 and with other Regulatory compliance requirements.
• Experience in handling deviations, investigations, root cause analysis, risk analysis, and corrective/preventive action plans.

· Quality certification desirable (e.g., CMQ/OE, CQE, CQA).

A bit about you – do you fit this description?

• In-depth knowledge of QA principles, design concepts, industry practices and standards, and development of QMS.
• Strong written and verbal communication skills in the English language.
• Strong project management and documentation skills.
• Demonstrated competence in using computer programs such as MS Word, Excel and PowerPoint.
• Attention to detail
• Working knowledge of statistical methods associated with six sigma and quality control.
• Understanding of applicable work instructions, SOPs, and ISO standards.
• Ability to maintain a professional and respectful relationship with co-workers and Company representatives.
• Strong technical writing and communication skills.

What We Offer

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.