To Assure product quality and compliance to procedures throughout the product life cycle, using a quality system and risk based approach that is appropriate for the intended use of the product. Lead improvements and corrective actions and support the organization as a QA representative, working directly with customers and on cross-functional teams within the organization.
Analyze customer complaints to determine which are regulatory reportable and coordinate activities with internal, field, and end use customers. Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Communicate event investigation results via regulatory reports and written communications, as appropriate.
1. Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
2. Apply clinical knowledge, as related to product application, to evaluate identified complaints. Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
3. Establish regulatory reportability decisions using event investigation and regulatory decision models.
4. Write Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
5. Compose written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable.
1. Assures conformance to established quality assurance processes and standards for development, manufacturing and testing of products through review of:
-Customer and product requirements, including QC specifications
-Product labeling, including instructions for use, certificates of analysis, and labels
-Product stability documentation
-Change control packets
-Method and process validation documentation, as required
2. Serve as an independent Quality Assurance (QA) resource on new and custom product development teams as applicable.
-Review and approval of new product development documents
-Product and customer requirements
-Design verification and validation protocols and reports
-Intended use statements
-Participation in design transfer of new products into production
-Review and approval of custom product development documents
3. Support products throughout all phases of product lifecycle from development through on-market support.
4. Ensures product documentation complies with internal procedures, external quality standards, and customer requirements.
5. Facilitate product or process improvement projects within product quality or quality system processes.
Mentor other employees on quality assurance requirements, processes, and procedures.
6. Work directly with customers to resolve complaints, support customer audits, and develop and improve customer relationships.
7. Understand and comply with ethical, legal and regulatory requirements applicable to our business.
8. Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Has a general knowledge of technical alternatives and an understanding of their impact on the systems environment.
1. University degree (B.S., M.S., or Ph.D.) in a biological or chemical science and a minimum of 6-10 years related experience in quality control, quality assurance, product support, manufacturing, or genetic identity testing. Note that advanced degrees may be considered towards years of experience.
2. Working knowledge of quality management systems, including 21 CFR 820 and ISO13485.
3. Ability to understand basic statistical concepts and analytical data.
4. Ability to communicate (in written and oral forms) in a concise, clear, and accurate manner.
5. Proven ability to work constructively with a broad range of people, backgrounds, and functions.
6. Ability to perform analysis of complex problems or data requiring in-depth evaluation of various factors.
7. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
8. Proficiency with basic word processing and spreadsheet software.
1. Technical knowledge or experience in scientific areas specifically applicable to Promega products and molecular technologies, such as sequencing and PCR testing (including identification of primers and PCR conditions).
2. Experience with ERP and EQMS software systems.
1. Ability to wear basic safety apparel (safety glasses or goggles, lab coats, and protective gloves).
2. Ability to use computers in an interactive manner for extended periods of time.
3. Ability to travel up to 10% of the time.
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.