Position: Product Development Quality Assurance Manager
Reports to: Quality Manager
The Product Development Quality Assurance Manager role is to ensure compliance to the Product Development Process within the Company’s Quality Management System. This role will lead the quality engineering team and have a strong focus on the cross functional Product Development Process which interfaces with Business Development, Marketing, Product Development, Research & Development, and Manufacturing.
- Define and maintain quality processes in support of the Product Development Process.
- Ensure Product Development process is implemented across the organization.
- Manage a team of Quality Engineers assigned to ensure that the PDP is followed within each project team.
- Define and maintain architecture for tools used to trace and document design control activities
- Lead quality training initiatives for employees.
- 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 external vendors.
- Reviewing responses to audit findings for completeness and effectiveness
- Designs and runs reports for managing quality assurance activities.
- Support Management Reviews of Quality through strategic reporting and continuous evaluation of KPIs and their value to the organization.
- Support effective corrective action and preventive actions (CAPA) process, 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.
- 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 6-8 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 email@example.com.