Principal Quality Engineer - Risk Management

Medline•Northfield, MN

20h•Hybrid

About The Position

Responsible for leading and managing quality projects throughout the quality organization. Collaborate with cross-functional teams, both internal and external to quality, and serve as a subject matter expert to ensure compliance to applicable regulations and standards; Support strategic initiatives with the goal of continually improving our global quality system as well as emergency support when unexpected challenges arise that meet your area of expertise; Plays a vital role in bridging the gap between conceptual design and practical manufacturing, contributing to the efficient and cost-effective production of high-quality products.

Requirements

Bachelor's degree in mechanical engineering, biomedical engineering, electrical engineering, software engineering, or related science.
At least 7 years of experience in pharmaceutical manufacturing.
Position requires travel up to 30% of the time for business purposes (domestic and international).
Demonstrated leadership abilities, including: Lead project teams by providing structure and delegating tasks in accordance with the skills of each team member.
Promote an engaging atmosphere within the group that helps foster open dialogue and is inclusive to all.
Independently manage projects to ensure deadlines are met and any delays are communicated/mitigated proactively.
Demonstrated Critical Thinking and Problem Solving abilities, including: Collaborating with cross-functional teams and internal customers as a key contributor and/or project manager, driving solutions and producing results for major projects such as QMS Improvements, Cost Savings opportunities, Process alignments, software launches/improvements; ensuring inputs and stakeholder needs are met.
Managing and engaging on multiple projects with competing needs and resource requirements.
Change management and leadership experience associated with process and QMS enhancements.
Improving organizational efficiencies by solving challenging and ambiguous problems with system and process solutions.
Sound judgment, ability to quickly evaluate information to make decisions while mitigating risk to the business.
Capable of maintaining a sense of calm during crisis management to identify and present unique solutions.
Exposure to statistical techniques and data collection methods to aid decision making based on data.
Good understanding of auditor expectations, able to properly document actions taken and support them through objective evidence.
Able to identify compliance gaps and set forth actions to correct deficient areas.
Demonstrated Communication and Interpersonal abilities, including: Communicating project status and complex subject matter to directors, vice presidents and executive members, to provide insight into the current state of the business or project, and as required, inspire the envisioned end state.
Understanding of when written or verbal communication is required and ability to tailor the information to a variety of audiences (quality, division, individual contributor, management etc.).
Through PowerPoint or other presentation mediums, able to confidently present to both small and large groups of varying audiences.
Demonstrate the capability to transfer technical knowledge to team members through formal training sessions, one-on-one interactions, and hands-on practical experiences.

Nice To Haves

Some medical device engineering and/or quality assurance experience preferred.
At least 10 years of experience in pharmaceutical/medical device engineering and/or quality assurance.
Deep expertise in risk management, design controls, and process controls.
Proven ability to successfully driving continuous process improvement.
Skilled in risk assessments, pFMEA development, root cause analysis, investigations, and CAPA implementation.

Responsibilities

Lead project initiatives throughout the quality organization by collaborating with cross-functional teams.
Present project deliverables to the lead team as well as communicate/train affected groups on procedural or process changes.
Identify, lead and drive opportunities to improve the Quality Management System through increased efficiency or more robust compliance to applicable regulations.
Leverages their understanding of the QMS to lead root cause activities as well as planning the corrective or preventative actions for critical quality concerns.
Ensure actions are completed in a timely fashion with appropriate resources and supporting evidence is properly documented.
Evaluate Cost of Quality metrics to identify cost savings opportunities.
Propose projects to the lead team and execute on the implementation of approved projects.
Manage and provide process guidance for manufacturing or corporate functions, ensuring process management is consistently applied across all corporate divisions, manufacturing sites and groups.
Proficiency in identifying, assessing, and managing risks associated with product and/or process development projects.
Apply industry-standard risk management tools and techniques (e.g., FMEA, fault tree analysis) to identify and mitigate potential risks.
Complete necessary documentation related to risk management activities, including risk assessment, risk mitigation strategies, and risk control implementation.
Create and deploy a risk management process that analyzes design and process control and connects this information to change control, product release, investigations, post-market activities, etc.
Provide training guidance on risk management and risk-based decision making.
Ensure the origination can articulate the risk process and ICH Q9 in regulatory inspection.
Participate and sometimes lead "SWAT" activities to resolve critical design and manufacturing issues and advise how to leverage risk management principles to resolve.