Quality Engineer

Your Role

As a Quality Engineer, you'll lead quality system improvement projects for Promega's medical device business, work governed by ISO 13485 and FDA's Quality Management System Regulation (QMSR). You'll also be a compliance resource as Promega builds its capabilities in Active Pharmaceutical Ingredient (API) manufacturing. You'll scope and drive projects from charter through implementation and improve key processes. You'll support API nonconformance review and GMP compliance, and investigate escalated complaints.

Core Duties

• Works with internal and external stakeholders and managers to define issues, select projects, and prioritize work; assure projects align with business and quality system objectives; create project charters, work plans, schedules, issues logs, and risk management plans.
• Develops project, process, instrument and product plans addressing key requirements, deliverables, timing, and assignments; writes or establishes methods or procedures to ensure continued and improved process and system performance.
• Reports and/or presents project, instrument, or product progress/metrics to stakeholders; identifies issues detrimental to timeline, budget, or quality and recommends solutions.
• Uses quality, engineering and human factors concepts to design and implement product and process improvements to improve quality and lower costs.
• Develops, redesigns, and manages processes compliant with customer requirements, QSR and ISO 13485, including Process Controls and Supplier Controls.
• Serves as a compliance resource for contract-manufactured API products, monitoring adherence to API quality standards and implementing process improvements for GMP compliance.
• Supports review of nonconformance documentation for API products.
• Occasionally supports customer audits, complaint resolution, and relationship development.
• Uses Complaint Investigation procedures and Promega's Quality System procedures; applies problem-solving skills in investigations and communicates investigational work.
• Works with management on urgent/critical activities or projects needed for the business.

Key Qualifications

• Minimum BS degree or equivalent in engineering, technical and/or scientific discipline with minimum 4 years of engineering or design experience.
• Minimum of 3 years' experience in project management or supervision, especially in biotechnology or medical device areas.
• Demonstrated adaptability and willingness to learn and effectively use AI-supported tools; working knowledge of Visio, Microsoft Project, and CAD in a Windows-based environment.
• Demonstrated experience in achieving results in a rapidly changing cross-functional environment.
• Strong analytic and presentation skills for problem determination, decision-making and resolution.
• Over 2 years' experience in designing, developing, and supporting biotechnology, medical device, or API product lines.
• Demonstrated proficiency in digital tools and technology, including Microsoft applications and mobile platforms, with ability to leverage emerging technologies such as artificial intelligence.

Preferred Qualifications

• Independent, self-starter with proven results in problem identification, planning, communication, and project management.
• Able to work and communicate well with a diverse scientific, business, and organizational group.
• Experience in medical device and cGMP systems.
• Experience in Active Pharmaceutical Ingredient (API) manufacturing or contract-manufactured API compliance.
• Technical knowledge or experience in scientific areas applicable to small molecule drug manufacturing.
• Excellent oral and written communication skills, including formal presentations, coaching, and problem resolution.
• Ability to articulate technical and interpersonal issues and resolve conflict constructively.
• MS or greater in engineering or technical discipline.