Quality Assurance Engineer
15800 Northup Way Bellevue, WA 98008 US
Position Description: Protingent has an exciting direct hire opportunity for a Quality Assurance Engineer with our client in Everett, Washington.
- Contribute to development and implementation of the Quality Program for TPI. Author, revise, and manage the approval of site procedures and policies related to Quality.
- Provide Quality-related training to colleagues involved in the TPI enterprise.
- Initiate risk-management activities and involvement in risk-based decision making. Balance the requirements for safety, such as radiation safety, in all quality initiatives.
- Support the Quality Assurance CAPA system; assist in developing corrective actions; monitor implementation.
- Develop and implement a supplier qualification program. Monitor supplier performance.
- Participate in Quality system audits (supplier, customer, and internal audits) as required. Contribute to resolution of audit findings and follow up.
- Key contributor to Change Control involving product or process changes.
- Develop processes for validation/qualification of equipment, cleaning, and/or manufacturing processes. Review and approve results.
- Assemble, analyze, and report QA data metrics to detect trends and identify areas for improvement.
- Perform other general duties associated with the position as required by supervision.
- Bachelor’s level degree in Science or Engineering
- 5+ years’ experience in Quality or a regulated operational production environment (e.g., ISO 9001, cGMP or radiopharmaceutical industries).
- Experience working within a quality program compliant to FDA/cGMP requirements Title 21 CFR 210/211 and ICH Guidance; preferably, experience in an operational/production radiopharmaceutical facility.
- Certification in a Pharmaceutical Quality-related discipline a plus.
- Must have keen attention to detail with the ability to read and understand requirements such as federal regulations, national codes and standards. Interpret these standards into TPI documents and provide guidance to personnel regarding these requirements.
- Strong organizational and communication skills, including technical writing, teamwork and interpersonal skill.
- Prior experience in pharmaceutical Quality Assurance is required, and related certification(s) is a plus.
- Familiarity with ISO 9001 Quality Assurance standards, 21 CFR 210/211 regulations and ICH Guides.
- Must demonstrate flexibility in adjusting to changing priorities and schedules in a dynamic environment.
- Actual position starting level and title will be determined based on assessment of qualifications.
- Military experience is a plus
- The successful candidate will possess a high degree of trust and integrity, communicate openly and display respect and a desire to foster teamwork.
Benefits Package: Protingent offers competitive salary, 100% paid health insurance, education/certification reimbursement, pre-tax commuter benefits, Paid Time Off (PTO) and an administered 401k plan.
About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding and exciting work opportunities for our candidates.
Meet Your Recruiter
I have worked in Technical staffing for over 17 years in the Pacific NW primarily, and Nationally. My specialty is finding candidates for contract, contract to hire and direct hire jobs in Technical & Engineering fields for some of the greatest Hardware & Software product development companies around. I listen to what you are looking for and will ensure your resume looks great. I am honest and communicative throughout the hiring process. I am passionate about putting our Veterans back to work, and helping underrepresented people get into STEM careers.