Quality Engineer

Job Title: Quality Engineer

Location: Arden Hills, MN 55126

Duration: 12 Months Contract to hire

Job Description:

• This Quality Engineer on the Field CAPA and Design Quality team will lead cross functional teams to determine actionable root cause and implement effective solutions for high visibility issues impacting Active Implantable & Accessories product performance within the Cardiac Rhythm Management and Diagnostics (CRMDx) division.
• This role is for a strong technical individual, with an innate technical curiosity, who is seeking leadership, complex problem-solving, and project management experience.
• This individual will collaborate and partner with Research & Development, Regulatory, Marketing, Medical Safety, Manufacturing, Post Market, and other Quality organizations to achieve optimal results.
• They will also support other Design Quality work and projects as required in the areas of risk management, new product development, and sustainment.

Responsibilities:

• Leads cross-functional teams on complex product performance investigations, where suspected root cause is product design. Includes Nonconforming Events and Preventions (NCEPs), Corrective and Preventive Actions (CAPAs), and Field Action recommendations if applicable.
• Leads collaborative problem solving of complex technical issues using disciplined, methodical techniques. Tools used include DMAIC, Root Cause Analysis, 5 Whys, Cause & Effect Diagram, and Is-Is Not.
• Creates, maintains, and enhances cross-functional team partnerships. Provides guidance regarding technical strategies and approaches; works cross-functionally and across multiple sites in identifying and resolving technical issues. Represents the team at key global and divisional leadership forums.
• Creates and maintains detailed investigation documentation following Good Documentation Practice guidelines.
• Creates, reviews, and approves Quality System records for NCEPs and CAPAs.
• Presents updates in formal and informal reviews with all levels of the organization including high senior leadership at Medical Device Manufacturing client.
• Mentors and guides other cross-functional teams and engineers by providing technical guidance and consulting on execution of NCEPs and CAPAs. May include consulting across other BSC divisions.
• Focuses on continuous improvement by championing and fostering the execution of projects within the local and divisional Design Assurance organizations.
• Fosters a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Monitors and ensures compliance with company policies and procedures.
• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the

Quality Systems Duties and Responsibilities:

• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
• Quality Policy and all other documented quality processes and procedures.

Minimum Qualifications:

• Bachelor's degree in an engineering or related discipline, plus 4 years of relevant experience
• Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards.
• Experience in Medical Device industry
• Experience with non-conforming products/processes, CAPAs, Field Action decision making and other investigation processes.
• Demonstrated technical problem-solving & data analysis capabilities
• Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook.

Preferred Qualifications:

• Experience with Active Implantable medical technologies
• Experience with statistics and statistical analysis tools (e.g. MINITAB, Weibull )
• Strong ability to successfully multi-task and demonstrate adaptability
• Project management experience (direct or cross-functional teams)
• Strong business acumen and communication skills, with the ability to quickly establish impact and consequences
• Ability to collaborate and influence across multiple, cross-functional teams
• Demonstrated experience managing and leading multiple projects covering diverse engineering (i.e. Software, Hardware, Labeling) disciplines and functions.
• Self-starter with the ability to identify improvement opportunities.
• Comfort speaking to groups of individuals including divisional senior leaders.