Senior Quality Engineer
Help us to excel at building amazing devices which have a direct impact on patient care and lives.
Together, we can change healthcare worldwide. At Spaulding Medical, we push the limits of what technology can do to help restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Senior Quality Engineer leads building, managing and executing quality assurance process, documentation and compliance for a Class II medical device and cloud platform. Manage change requests, design documents, technical files, audits and conformity. Educate and facilitates Spaulding Medical leadership to align business strategy, investments and operations with quality assurance.
Senior Quality Engineer Job Duties:
Product Quality Assurance
- Develop and document hardware, software verification & validation protocols.
- Analyze and report on test results.
- Document errors and anomalies and assist with corrective and preventative measures.
- Work with Engineering team to verify and debug software and electronics.
- Ensure compliance to the appropriate Quality System and project Quality Plan
- Collaborate with other project team members and regulation professionals
- Acts as a functioning member of cross functional teams by providing technical expertise for projects or subprojects.
- Through ability to think critically, and see big picture, assist company in meeting or exceeding company objectives
- Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, IEC. ISO, CE, FDA and HIPAA requirements.
- Lead the Quality Assurance process and stakeholders in conformity to audit guidance, process improvements and quality delivery.
- Escalate potential impediments, risks and business opportunities and manage execution of continuous improvement efforts.
- Manage and complete required documentation, product demonstrations and audits including scheduling and facilitating 3rd party discussions and meetings.
Sr. Quality Engineer Skills & Qualifications:
Good Communication Skills, Self-Management, Detail Oriented, Documentation Skills, Analyzing Information, Informing Others, FDA, ISO, CE Regulations, Thoroughness, Microsoft Officer Proficiency.
- 4+ years of quality assurance experience ideally including management responsibilities
- Proven leadership in process optimization, notably in a medical device company including management experience, with strong results orientation.
- Ability to work collaboratively and partner with employees, leaders, clients, and vendors
- Problem solving & decision facilitation skills
- Experience with lean and continuous improvement events and techniques.
- Demonstrated capability to build a new quality management system.
- Strong communication skills, including communication with employees, clients, upper management, and vendors
WORKING ENVIRONMENT/PHYSICAL ACTIVITIES:
Standard office setting, clean room, conference room, customers, supplier visits.
Based in West Bend and Milwaukee, WI
Some travel may be required
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Interested in applying? Reach out to firstname.lastname@example.org today!