What are the responsibilities and job description for the Senior Principal Quality Engineer position at Medtronic?
The Ear, Nose, and Throat Operating Unit is a global leader and trusted partner for innovative ENT solutions that improve patient access, outcomes, and customer satisfaction. We partner with the ENT community to understand the needs of customers and patients, delivering solutions that improve lives as we embody a culture of accountability and trust.
Over the past 20 years, we have become the global market leader in three key segments – image-guided surgery, intraoperative nerve monitoring, and powered surgical instruments. We continue to launch valuable ENT solutions in these areas: tissue health, and balloon sinus dilation.
A Day in the Life
Provide Quality Engineering support to the organization by establishing and maintaining quality assurance standards that adhere to cGMP, ICH, and ISO regulations that pertain to pharmaceutical products. Quality oversight of various Quality functions as assigned (e.g. drug, product development, process development, Manufacturing Process controls and changes, Verification and Validation).
As a product expert in pharmaceutical Quality, the Principal Quality Engineer is responsible for working directly with CMC Leaders, Quality Control (QC), Regulatory, Research, and Development (R&D), Manufacturing Processes/ operations, Quality Assurance (QA), resolution of issues associated with process/manufacturing, In-Process Control (IPC), analytical methods, specifications, reference standards, testing, investigations, change control, regulatory submissions, international expansion and inspections related to QA activities related to drug product development and manufacturing.
Responsibilities may include the following and other duties may be assigned.
- Provides input and compliance review on the following records: Qualification/validation plans, protocols, & reports, Change Controls, Deviations, and CAPAs related to facility, utility, equipment, and processes.
- Acting as the Designated Representative works directly with manufacturing, the laboratory, and other departments responsible for GMP activities to resolve deviations and other compliance issues on time.
- Provides quality and compliance assessments to senior management as required and contributes to strategic direction or initiatives to achieve organizational effectiveness.
- Serves as the quality expert for assigned programs and makes strategic quality decisions throughout the product lifecycle. Provides a proactive front-end approach to product quality.
- Acts as the lead Quality input to ensure the product teams are fully aligned around the Quality Strategy. Provides direction and alignment across different functions and influences strategic and tactical Quality input to develop product quality strategies and life cycle management decisions for clinical and commercial products in alignment with overall product strategies and is accountable for decisions on product quality.
- Actively monitors product metrics and signals (e.g., cpk /stability, etc.) and initiates/supports improvement projects to enhance performance and /or mitigate quality or compliance risks across the development portfolio.
- Leads investigations in response to quality signals/complaint trends, CAPA, or critical deviations. Actively gathers necessary SME’s (e.g., Technical/Regulatory) and leads team to resolve.
- Collaborating with operations provides strategic and tactical Quality decisions regarding innovative technologies, industry best practices, new regulations, and processes in end-to-end supply chain operations.
- Owns the APR / PQR, coordinating cross-functionally to ensure regulatory requirements are met, and actions arising are managed to conclude.
- Interfaces with Regulatory Affairs to author, review, and approve filings, and represents Quality in product-related agency meetings.
- Trains and mentors other Quality department staff to perform quality duties.
- Bachelor's degree in engineering or science fields related to pharmaceutical products required
- Minimum of 10 years of experience in a QA or GMP environment for pharmaceutical products or advanced degree with a minimum of 8 years of relevant experience
Nice to Have
- Master’s degree preferred
- Minimum of 8 years experience in a QA or GMP environment for pharmaceutical products (including combination devices with a drug component).
- Experience with quality system elements about combination products (drug/device) and cGMP is strongly preferred.
- Strong written and verbal communication skills and attention to detail.
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, 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 want to 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.
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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.
Committing to our employees' lives is at our values' core. We recognize their contributions. They share in the success they help to create. We offer many benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here.
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) on page 6 here.
The provided base salary range is used nationally (except in certain CA locations). The rate offered complies with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.
