At scPharmaceuticals, we are focused on exploring, developing, and commercializing innovations that will expand and advance the outpatient care of acute conditions. Our goal is to provide targeted solutions for patient populations and disease states where outpatient management will have the greatest impact. The device focused Manager of Quality Engineering will play a key role in designing and managing the product complaint process and supplier quality management program for 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.
- Designs, establishes and administers the process for handling customer complaints including data entry, trending, reporting and managing CMO complaint investigations
- Conducts complaint trending, determines course of action and reports metrics/findings and associated action plan 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.
- Provides oversight and input to test plans for verification and validation activities for new product introductions and product improvements.
- Maintains 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 assigned as needed within the Quality Management Systems.
Education and Experience Requirements
- Bachelor’s degree in engineering or related math/science discipline
- 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-maker
- You possess strong communication skills
scPharmaceuticals is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. It is the Company’s policy and intent to provide equal opportunity in employment, development and advancement without regard to a race, color, religious creed, sex, pregnancy, sexual orientation, gender identity, age, national origin, physical or mental disability, genetic information, ancestry, military service or veteran status, marital status or any other category protected under applicable federal, state or local law.