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Quality Assurance Engineer
3315 Seaway Blvd. Everett, WA 98203 US
Job Description
Position Description: Protingent has an exciting direct hire opportunity for a Quality Assurance Engineer with our client in Everett, Washington.
Job Requirements:
- 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.
Job Qualifications:
- 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.
Job Details:
- Direct Hire
- Salary Range Level 10: $105,236 - $157,855
- Salary Range Level 11: $116,030 - $193,384
- *Typically, our employee salaries are within .90 – 1.0 of the mid-point of the posted salary bands. Any salary offered within the posted salary band is based on market data and commensurate with the selected candidate’s qualifications and experience. This range is specific to Washington State.
- ITAR obligations are associated with this role, U.S. citizenship, U.S. legal permanent resident status, or protected person status under 8 U.S.C. § 1324b(a) (1), (3) is required.
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
Laura Duarte
I have been in Technical Recruiting for over 20 years. I specialize in hiring people for technology, engineering, manufacturing, and operations jobs for various exciting industries nationwide, such as consumer electronics, medical devices, space/aerospace/avionics, and nuclear-clean energy. I will listen to you and guide you through the entire job application and interviewing process in a fun and clearly communicated way. My philosophy has always been to be an enthusiastic learner of new technologies and keep the big picture in mind while continuing to be honest, organized, and proactive. I am passionate about helping others find an exciting and fulfilling job that aligns with their goals. I am diversity-focused and especially love helping under-represented folks & Veterans into STEM careers. I approach every job seeker with empathy, equity, and respect.