Position: Quality Assurance Engineer
Reports to: Director of Quality
Position Location: Company HQ in Suburban Philadelphia, PA
The Quality Assurance Engineer role is to assist with maintaining compliance to ISO 9001 processes and procedures within the Company’s Quality Management System. This role will have a strong focus on the cross functional Product Development / Product Lifecycle Process which interfaces with Business Development, Marketing, Product Development, Research & Development, and Manufacturing. This position will be responsible for assisting with Internal auditing and Document Control.
The Quality Assurance Engineer will develop, implement, and maintain quality assurance processes for compliance to ISO 9001 and ISO 13485. The position is also responsible for implementing processes for compliance with safety, quality, and regulatory standards requirements for worldwide distribution. The Quality Assurance Engineer will perform analysis of reports to identify trends and recommends updates or changes to quality standards and procedures when necessary.
- Define, maintain, and monitor quality processes with particular focus on the Product Development / Product Lifecycle Processes
- Ensure the Product Development process is implemented across the organization as required
- Support process audit activities including but not limited to conducting routine/periodic quality assurance assessments to measure and ensure adherence of processes and procedures by internal personnel and contract manufacturers
- Reviewing responses to audit findings for completeness and effectiveness
- Support KPI evaluation and analysis with a focus on Product Development metrics for Management Reviews
- Support effective corrective action and preventive actions (CAPA) processes, including but not limited to the tracking, trend analysis, root cause analysis, and implementation of process improvement measures and effectiveness checks
- Provide support during external audits
- Assist with implementation of an electronic product life cycle and quality management system
- Perform other duties and projects as assigned
Required Skills & Qualifications:
- Bachelor's degree in Science, Engineering, or related field preferred. The position requires 5 years of related experience with medical device quality management systems with a Bachelor’s degree; or 3 years of experience and a Master’s degree
- CQA or CQE preferred
- Strong understanding of medical device design control, product development process requirements, quality system principles and requirements per ISO 9001, CFR Title 21 Part 820, ISO 13485, and ISO 14971
- Process oriented
- Internal auditing experience
- Root cause analysis experience
- Excellent communication skills
- Authorized to work within the United States
Preferred Skills & Qualifications:
- Experience with internal and/or third-party quality audits.
- Experience with Arena, SharePoint, JAMA, JIRA, and Confluence software tools is a plus.
- Experience with Document Control is a plus.
- Ability to work independently with minimal supervision.
- Product Development
- Research & Development
- Manufacturing & Supply Chain
Cultural, Behavioral and General Characteristics
- Work standards/high work ethic – initiative and drive
- Innovativeness & creativity
- Self-sufficient, self-driven, self-motivated (work with minimal supervision)
- Ability to think through complex issues and solve problems
- Desire to share information and support a transparent culture
- Technical translation