JOB OBJECTIVE: Utilize quality principles and practices to manage and improve quality processes and ensure quality system compliance.
1. Review data, documents and other quality records for compliance in meeting product and system requirements.
2. Maintain records of reviews and provide feedback or take action if requirements are not fulfilled. Assist other stakeholders in reviewing problems and issues and taking appropriate action.
3. Use scientific and quality based principles to defined product and procedural requirements and lead or assist others in developing procedures, labeling, certifications and other records of product quality and system compliance.
4. Track metrics applicable to review processes and report results and suggestions to management or other stakeholders.
5. Maintain training and certification requirements for position, and assist others in developing training content or training support as assigned.
6. Ensure that quality and production stakeholders are informed and maintain active lines of communication to provide feedback, and assist in problem resolution.
7. Understand and comply with ethical, legal and regulatory requirements applicable to our business.
8. Working with others, make improvements to the Quality System to ensure compliance with Quality System Regulation (QSR) and ISO13485; including Design Control, CAPA, Nonconformance Systems, Process Controls, Management Controls and other QS sub-systems.
9. Understands and complies with ethical, legal and regulatory requirements applicable to our business.
1. Represent QA in special projects as assigned.
2. Work with QA and/or other process or business leaders on urgent/critical activities or corrective actions needed for the business.
3. Internal auditing of the Quality System to QSR and ISO13485.
1. Minimum AS degree or equivalent in technical and/or scientific discipline with some manufacturing/QA experience.
2. Minimum 0-2 years’ experience in QA or production activities, especially in the biotechnology or medical device areas.
3. Demonstrated knowledge and experience in various computer skills, including Windows, Word for Windows, Excel, and Outlook, as well as familiarity working in a windows-based environment.
4. Demonstrated experience in detailed review work and following procedures, especially in a QSR or ISO quality system.
5. Good evaluation and analytic skills for problem identification and communication to others.
6. 0-2 years’ experience in QSR and/or ISO13485.
1. Independent, self-starter with proven results in QA processes.
2. Ability to work and communicate well with other key groups to achieve improvement and operational results.
3. Experience in QA review, especially in a medical device company.
4. Good oral and written communication skills.
5. Ability to work with others to achieve successful results.
6. Certified auditor as recognized by American Society of Quality or similar credentials.
1. Ability to work with computers.
Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.