QA Associate

The QA Associate is responsible for assisting with the development and implementation of policies and procedures to ensure that quality standards are met during product development, production and commercialization. Participates in testing of processes and products and provides input to strategic decisions that affect the functional area of responsibility. Capable of resolving escalated issues arising and requiring coordination with other departments.

ACCOUNTABILITIES:

• Execute quality systems activities such as:
•       MasterControl/QMS system maintenance and ongoing effectiveness
•       Internal audit
•       Procedure updates
•       Quality objectives/metrics
• Execute quality assurance activities such as:
•       Document Control
•       External Standards Management
•       Non-conformance
•       CAPA
•       Complaint/Adverse Event/Field Action
•       Supplier Audit
• Execute quality engineering activities such as:
•       Risk Management
•       Annual Risk Review
•       Equipment IQ/OQ/PQ
•    Validations

• Maintains a leading edge understanding of the regulatory and quality processes required in designing, manufacturing and post market performance of ophthalmic devices in order to find new and novel opportunities to improve product quality and reduce cost.
• Effectively implements enhancements and improvements as necessary to ensure maintenance of state-of-the-art processes and compliance to pertinent international standards and regulatory requirements, e.g., ISO 13485, 21 CFR 820, European MDR, etc.
• Ensures effective implementation and management of reference standards in the execution of quality-related actives, e.g., ISO 14971, IEC 62366, etc.
• Fosters consistent quality input and partners with manufacturing, engineering and operations to support new product development and sustaining activities.
• Provides project oversight and management, including initiating and leading cross-functional teams.
• Generates the development quality timelines for new product introduction and sustaining quality activities.
• Oversees timely and thorough investigation, root-cause analysis, completion, and effectiveness review of corrective and preventive actions (CAPA).
• Uses appropriate statistical tools/methodologies to drive regulatory and quality improvements.
• Other duties may be assigned as deemed necessary by the supervisor.

EDUCATION/EXPERIENCE REQUIREMENTS (including certifications, licenses, etc.):

• Bachelor Degree is required, technical discipline is preferred.
• Effective written and verbal English communication skills
• 3+ years of progressive experience working within a regulated industry related to medical devices.

COMMUNICATION SKILL REQUIREMENTS:

• Strong verbal and written communication skills essential
• Willingness to be flexible and adaptable to changing priorities

MATHEMATICAL SKILL REQUIREMENTS:

• Experience in application of statistics to quality systems.

REASONING SKILL REQUIREMENTS:

• Effective analytical and problem-solving skills
• Ability to make sound decisions about scheduling, allocation of resources, and managing priorities

TECHNICAL SKILL REQUIREMENTS:

• Able to apply extensive technical expertise and has knowledge of other related disciplines
• Excellent computer skills, including working knowledge of common QA Document Control and QMS, ERP software and databases
• Proficient in MS Office Suite of products

PERFORMANCE METRICS:

• Ensure compliance with requirements as outlined in quality policy and objectives.
• Ensure completion of individual objectives.

CIM Group is committed to bringing together humans from different backgrounds and perspectives, providing employees with a safe and welcoming work environment free of discrimination and harassment. We strive to create a diverse & inclusive environment where everyone can thrive, feel a sense of belonging, and do impactful work together. As an equal opportunity employer, we prohibit any unlawful discrimination against a job applicant on the basis of their race, color, religion, gender, gender identity, gender expression, sexual orientation, national origin, family or parental status, disability*, age, veteran status, or any other status protected by the laws or regulations in the locations where we operate. We respect the laws enforced by the EEOC and are dedicated to going above and beyond in fostering diversity across our workplace.
*Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. A reasonab