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Quality Assurance Specialist
2 months ago
At The IMAGINE Group, we're committed to delivering exceptional quality solutions to our clients. As a Quality Assurance Engineer, you'll play a critical role in ensuring our medical device products meet the highest standards of quality and regulatory compliance.
Key Responsibilities:- Lead the timely completion of supplier corrective action requests (SCARs) and corrective action and preventive action (CAPA) activities.
- Collaborate with internal functions to own corrective actions, including training, process improvements, SOP updates, quality audits, and validation efforts.
- Prepare and present reports and compliance documentation to medical customers as necessary.
- Maintain and review documentation for regulatory submissions and inspections related to product quality.
- Ensure products meet all regulatory requirements, including FDA, ISO, and other relevant quality standards.
- Assist in maintaining and developing our Quality Management System (QMS) to the requirements of ISO 9001:2015, Quality Manual, and current company objectives.
- Provide guidance and training on medical quality standards and best practices to internal teams.
- Design inspection and testing mechanisms; conducts quality assurance tests and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Lead cross-functional teams to perform root cause analysis events and ensure the completion of action items, which may include training, CAPA activities, quality audits, validation efforts, standard work revisions, etc.
- Experience in supplier and/or customer quality in a manufacturing environment.
- Experience with ISO 9001, Root Cause Analysis, SCARs, CAPAs.
- Detail-oriented with robust verbal and written communication skills.
- Working knowledge of utilizing statistical analysis tools such as, control charts, ANOVA charts, sample size determination, etc.
- Robust analytical and problem-solving skills, with the ability to interpret complex data and provide actionable insights.
- Able to read and interpret written specifications and maintain documentation required internally and by the customer.
- Microsoft Office suite of products experience is required.
- Working knowledge of Six Sigma methodologies.
- Robust skills in gathering & understanding data from systems.
- Self-motivated and the ability to prioritize tasks.
- Ability to work well in a team and perform with little supervision.
- Follow and support all quality, management, and corporate policies and instructions.
- Bilingual or multilingual proficiency in any language (including ASL) preferred.
The IMAGINE Group offers a competitive salary range of $75,000 - $110,000/year, depending on location. In addition to base salary, the total compensation package may also include participation in a bonus, commission, or incentive program. Imagine offers benefits including medical, dental, and vision coverage, paid time off, disability insurance, 401(k) with match, life insurance, and other voluntary supplemental insurance coverages, plus tuition assistance, caregiver leave, adoption assistance, and employer/partner discounts.
The IMAGINE Group is an equal opportunity employer and does not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Diversity and Inclusion is a critical part of our commitment to deliver innovative solutions to our clients and provide a great place to work for our entire IMAGINE family.
