Reports to: Quality Assurance Manager
Position Location: Company HQ in Suburban Philadelphia, PA
The Quality Engineer role will be responsible for design quality engineering activities that span the product development process and design transfer to manufacturing. They will ensure that design control activities are executed in accordance with company QMS processes, and ensure proper utilization of company design control tools.
- Act as quality assurance support for the design and development of instruments, facilitating the application of design/change controls, risk management, quality plan and implementation of design and development plan.
- Coordinates for both new products/processes and changes to existing products/processes ensuring verification and validation plans assess if requirements are met. Oversee the execution of verification and validation plans in conjunction with engineers and applications.
- Actively perform design control process audits to identify and implement improvement initiatives.
- Ensures design control tools are effectively utilized.
- Ensures systems configuration are properly documented and maintained.
- Work closely with R&D, Manufacturing, Quality, and Applications Support management to prevent non-conformities and provide solutions to complex issues.
- Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations.
- Perform root cause analysis of product quality issues. Apply appropriate tools (e.g. statistics, 5 why, fault tree analysis, etc.). Work with peers to develop corrective actions.
- Support CAPA processes by performing investigations and root cause analysis and determining action plans and driving the actions to closure.
- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of instrument defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
- Carries out duties in compliance with established business policies.
- Demonstrates commitment to assuring effectiveness of Quality Management System per ISO, and any applicable regulatory agencies.
- Perform other duties and projects as assigned.
Required Skills & Qualifications:
- Bachelor’s degree in Science, Engineering, or related field preferred. Combination of education and relevant experience in lieu of bachelor’s degree may be considered.
- Minimum 3-4 years of industry experience with new product development under a QMS.
- Minimum 2 years of industry experience with medical device quality management systems.
- Strong understanding of medical device design control and quality system principles and requirements per CFR Title 21, Part 820, ISO 13485, and ISO 14971.
- Process oriented
- Internal auditing experience
- Root cause analysis experience.
- Excellent communication skills.
- Ability to work within the United States.
- Willing to relocate to the Chadds Ford, PA region
Preferred Skills & Qualifications:
- Experience with third-party quality audits.
- Experience with SharePoint, JAMA, JIRA, and Confluence software tools.
- Previous experience in LC or LC/MS. Experience in Ion Mobility a plus
- Ability to work independently
- Product Development
- Research & Development
- Manufacturing & Supply Chain
- Supply Chain Partners
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): figure it out
- Ability to quickly learn SLIM technology and apply it
- Ability to think through complex issues and solve problems
- Desire to share information and support a transparent culture
- Technical translation
If interested, please send a cover letter and current CV to firstname.lastname@example.org.