Senior Quality Engineer
Senior Quality Engineer
A device focused Senior Quality Engineer that will be responsible for managing the product complaint process and supplier quality management for the medical device suppliers. Additionally, this position will assist in administering QMS programs including change control, NCRs and SCARs. This position reports to the Vice President of Quality.
- Establishes and administers the process for handling customer complaints including data entry, trending, reporting and managing CMO complaint investigations
- Trending of complaints and reporting of metrics to Senior Management.
- Monitors and improves quality at device suppliers. Evaluates input from audits, complaints, and quality metrics at device contract manufacturers. Establishes corrective and preventive actions and other improvement requirements and plans as necessary. Ensures corrective and preventive actions are effective.
- Provide oversight and input to test plans for verification and validation activities for new product introductions and product improvements.
- Maintain the risk management process for device and combination products through periodic review of product performance versus anticipated performance documented in the risk management program.
- Other related responsibilities to be assigned as needed within the Quality Management Systems.
Education and Experience Requirements
- Bachelor’s degree in engineering or related math/science discipline
- 3-7 years of experience in quality engineering in the medical device or related industry
- Experience with commercial product complaint management
- Ability to work in a virtual team environment
- Six Sigma root cause analysis and problem solving training and experience preferred.
Skills and Abilities
- You are self-directed and able to work at all levels of the organization with a “hands on” management style to accomplish goals
- You thrive in small company environments and know how to maximize resources. You understand, appreciate, and desire to work in a growing organization
- You have an entrepreneurial mindset and approach to business challenges
- You act with impeccable integrity and treat your colleagues and business partners with the utmost respect
- You understand strategy, transition to execution, and effectively lead teams and/or peers through this process
- You strive for excellence and expect the same from your team and colleagues
- You have strong collaboration skills capable of influencing internal and external decision-makers
- You possess strong communication skills
scPharmaceuticals is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.