Senior Quality Engineer

The Senior Quality Engineer will be responsible to support the planning, management, and execution of the start-up, commissioning, and validation of new radionuclidic separation instruments, radiochemical manufacturing/filling processes, and assist in other projects. They will review and approve Validation Protocols, such as Product Design, Installation, and Operational, Validation Plans and Protocols. The Senior Quality Engineer may also be responsible for Supplier Quality Assurance activities such as supplier rating, qualification & auditing, change review and approval, risk analysis, and supplier continuous improvement activities.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:

1. Act as a quality assurance representative on cross-functional product development teams.
2. Lead and develop the Human Factors Engineering evaluation program for the company.
3. Consistently follows program status, participates in cross functional decision making, and insures team decisions are consistent with regulatory and quality system requirements
4. Proactively provides input, guidance, as needed on development of specifications, project plans, test protocols/reports, etc.
5. Is primary quality approver of product development team deliverables for Phase 1 and Phase 2, ensuring documentation meets regulatory and internal product development process requirements.
6. Participates as key team member in risk management activities including PFMEA, DFMEA, risk mitigations, and directs subsequent integration into Product/Process Risk & Hazard Analysis.
7. Coordinate input and standardization of all QA Product Development Project support (Phase 1 and Phase 2) and representation.
8. Ensure requirement traceability is maintained between requirement documents and V&V.
9. Escalate quality issues and concerns as appropriate to quality and engineering management.
10. Develop Product Validation Plans based upon Functional Requirement Specifications provided by Product Development.
11. Report and catalog protocol identified product defects to PD and Science departments for resolution.
12. Provide and lead cross functional teams in defect resolution. Track progress of resolution and re-verify/validation defect corrections.
13. Expected to execute improvements based on technical knowledge and experience to improve the validation process and ensure compliance with appropriate regulatory agency validation requirements, company standards, and current industry practices.
14. May provide Supplier Quality Engineering expertise in the areas of Supplier Auditing, Rating, and defect resolution.
15. Lead a team of individuals in the execution of failure mode analysis of processes/product, statistical analysis, and design of experiments.
16. Review critical analyses of data (clinical, preclinical, and manufacturing) and independently interpret and develop conclusions; perform reviews of clinical/preclinical/manufacturing protocols and studies reports.
17. Responsible for organizing data and preparing appropriate documentation for assigned projects (Phase 1 and Phase 2) in the areas of equipment, software, process, cleaning, control system, and critical system validation.
18. Effectively communicate safety and quality issues raised by customers or staff in a timely manner.
19. Support NorthStar’s Quality System and Health & Safety Program by following policies and procedures.

Ability and willingness to travel, both domestically and internationally, up to _10_% of the time.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

A Bachelor’s Degree in Physical Sciences and six or more years’ experience in the pharmaceutical/medical device industry and in quality assurance and product development support; or equivalent combination of education and experience. Sound knowledge of applicable portions of agency guidance, and regulations (21CFR Part 210/211/820, ISO 13485, and ICH Q7).

Proficient knowledge of Microsoft Office software programs, including Outlook, Word, and Excel.

• Excellent communication skills, verbal and written
• Ability to work in a team environment, as well as independently
• Ability to handle multiple tasks simultaneously
• Ability to work in a fast-paced environment
• Adaptable to change in the work environment

If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line



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