Yoh Life Sciences
is hiring for a senior level QA Specialist,
for our diagnostics customer in North County San Diego. The senior level QA Specialist will focus on technical files, training, software management and design. Experience needed in report writing, risk assessments, and NCR's within diagnostics or medical device companies. You must have strong verbal and written skills to write reports for yourself and others on the quality team.
Schedule -
8am - 4:30pm (Onsite)
Location -
Carlsbad
Qualifications
- Proven work experience as a Quality Assurance Specialist or similar role
- Thorough knowledge of methodologies of quality assurance and standards
- Excellent numerical skills and understanding of data analysis/statistical methods
- Strong attention to detail and a results-driven approach
- Strong cGMP and GDP knowledge
- Reliable and trustworthy
- Bachelor's degree in relevant field
- 5+ years of relevant experience
- Knowledge of FDA regulations (21 CFR 820 and 21 CFR 210/211) and ISO13485 is preferred
- Knowledge of IVDR and CE Marking, preferred
- Knowledge of ISO 14971 preferred
- Experience in quality control preferred
- Strong computer and Excel skills
- QMS software experience preferred (QT9)
- Excellent verbal and written communication skills
- Strong interpersonal skills
- Excellent analytical skills
- Strong problem-solving skills
- Strong organizational skills
- Ability to work well in a team environment
Responsibilities
- Manage product technical files
- Support scientists, project manager with design history files, including but not limited to, reviewing protocols and documents and verifying file contents.
- Keeps up to date on industry standards, specifications, and regulations, and is diligent about incorporating these requirements into the production-quality process
- Support ISO audits, client audits and FDA inspections
- Plan and schedule internal audits too ensure routine quality compliance and make appropriate recommendations
- Batch record reviews, QC inspections and release of product
- Support management review meetings
- Prepare and present reports and metrics related to quality assurance and compliance activities
- Manage and review customer complaints and non-conformances
- Assist in the development of training material for quality assurance and compliance staff
- Manage training matrices and personnel training
- Support document control processes
- Support quality and master validation plans
- Support all areas of quality assurance
- Support Facilities, Assay Development, Clinical Research, Manufacturing, Engineering, and Commercial teams.
#IND-SPG
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit
https://www.yoh.com/applicants-with-disabilities
to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
YOH Services LLC
Jan 30, 2025