Quality Engineer

OUR TEAM: The Product Quality and Compliance (PQ&C) team at Promega brings together Product Quality Assurance, Quality Systems, and Compliance in one collaborative organization. We make sure Promega's Research Use Only, IVD medical device, and Active Pharmaceutical Ingredient (API) products meet high quality standards for our customers, and that they comply with regulations across a global portfolio. We cover everything from product release and complaint investigation to quality system processes, audits, and regulatory inspections. We work closely with Manufacturing, R&D, Operations, and Supply Chain to find and fix the root causes of quality issues. We value curiosity, accountability, and practical judgment. We're also adopting AI-supported tools so we spend less time on administrative work and more on improving quality.

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. Your work will move between RUO, device and API, often in the same week, and you'll help stakeholders see risks to timeline and quality before they become problems. The role has real room to shape how our quality systems grow alongside Promega's expanding organizational capabilities.

JOB OBJECTIVE: Utilize design, engineering and quality principles and practices to support the design and manufacture of products and implement and improve key business and quality processes. Actively support Promega's growing Active Pharmaceutical Ingredient (API) business by monitoring compliance with GMP and customer requirements across API manufacturing, and lead quality system improvement projects aligned with ISO 13485 and other medical device regulations.

CORE DUTIES:

1. 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, as necessary. Actively manages partners, contractors and/or consultants in delivering solutions during project work.
2. Develops project, process, instrument and product plans addressing key requirements, deliverables, timing, and assignments needed for successful completion. Write or establish methods or procedures to ensure continued and improved process and system performance. Implements project, process, instrument, or product work in collaboration with other partners, departments, or teams. Create assignments and tasks and track completion against stated requirements. Address delays and other barriers in completion of tasks.
3. Reports and/or presents project, instrument, or product progress/metrics to stakeholders during course of work. Identify issues detrimental to the timeline, budget, or quality of the work, and recommend solutions to overcome identified issues. Ensure source data is verified and accurate. Summarize metrics and support management to present data.
4. Uses quality, engineering and human factors concepts, design and implement product and process improvements to improve quality and lower costs. Ensure products and processes meet customer, business, and regulatory requirements.
5. Develops, redesigns, and manages processes which are compliant with customer requirements, the Quality System Regulation (QSR) and ISO13485. Key systems include Process Controls, Supplier Controls, and other related QS sub-systems.
6. Serves as a compliance resource for contract-manufactured Active Pharmaceutical Ingredient (API) products, monitoring adherence to API quality standards and implementing process improvements to ensure ongoing compliance with external GMP requirements and customer standards.
7. Supports review of nonconformance documentation for API products, as needed, to ensure compliance with internal procedures and external quality standards.
8. Occasionally supports customer audits, complaint resolution, and relationship development, as needed.
9. Use and comply with Complaint Investigation procedures and Promega's Quality System procedures as appropriate to this position. Apply problem-solving skills, while performing investigations and communicate investigational work to internal and external customers as applicable. Recommend further action, as necessary.
10. Works with management with executive responsibility on urgent/critical activities or projects needed for the business.
11. Performs other duties as assigned to support departmental and business needs.
12. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
13. Embracing and being open to incorporating Promega's 6 Emotional & Social Intelligence (ESI) core principles in daily work.
14. Understands and complies with ethical, legal and regulatory requirements applicable to our business.

KEY QUALIFICATIONS:

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

PREFERRED QUALIFICATIONS:

1. Independent, self-starter with proven results in problem identification, planning, communication, and project management.
2. Able to work and communicate well with a diverse scientific, business, and organizational group to achieve improvement and operational results.
3. Experience in medical device and cGMP systems, especially in understanding requirements, identifying improvement targets, tracking results, and developing products.
4. Experience in Active Pharmaceutical Ingredient (API) manufacturing or contract-manufactured API compliance, including working knowledge of quality standards governing API products.
5. Technical knowledge or experience in scientific areas applicable to small molecule drug manufacturing.
6. Excellent oral and written communication skills, including formal presentations, coaching, and problem resolution.
7. Ability to articulate technical and interpersonal issues and resolve conflict in a constructive manner to ensure project success.
8. MS or greater in engineering or technical discipline.

PHYSICAL DEMANDS:

1. Ability to use a computer/Microsoft Office applications.

At Promega, we value diversity and strive to create an inclusive workplace. We are proud to be an Equal Opportunity Employer, making employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.