About the Company
Medtronic is a global leader in medical technology, alleviating pain, restoring health, and extending life for millions of people worldwide. We are committed to innovation and excellence, developing groundbreaking therapies and solutions that transform healthcare. Our Santa Rosa facility plays a critical role in manufacturing life-saving medical devices, ensuring the highest standards of quality and patient safety. Join a company where your work makes a tangible difference every day.
Job Description
We are seeking an experienced and highly motivated Quality Control Chemist II to join our dynamic team in Santa Rosa. This role is pivotal in maintaining the integrity and quality of our medical device products through rigorous chemical analysis and adherence to regulatory standards. The successful candidate will have a strong background in analytical chemistry, a meticulous approach to lab work, and a commitment to continuous improvement and career growth. This position offers a clear path for advancement and is compensated with top-tier pay reflecting the critical nature and expertise required for the role.
Key Responsibilities
- Perform complex chemical and physical testing on raw materials, in-process samples, and finished medical device products according to established procedures and specifications.
- Operate, maintain, calibrate, and troubleshoot a variety of analytical instrumentation including HPLC, GC, UV-Vis, FTIR, and dissolution apparatus.
- Analyze and interpret data, document results accurately, and maintain detailed laboratory records in compliance with Good Manufacturing Practices (GMP) and ISO standards.
- Investigate out-of-specification (OOS) and out-of-trend (OOT) results, participate in root cause analysis, and recommend corrective actions.
- Develop, validate, and transfer new analytical methods as needed.
- Contribute to the continuous improvement of QC processes, procedures, and systems.
- Train junior chemists and provide technical guidance as required.
- Ensure all work is performed safely and in compliance with all company and regulatory guidelines.
- Collaborate with R&D, manufacturing, and quality assurance teams to resolve quality issues and support product development.
Required Skills
- Bachelor's degree in Chemistry, Biochemistry, or a related scientific field.
- Minimum of 4 years of experience in a Quality Control laboratory, preferably within the medical device, pharmaceutical, or biotechnology industry.
- Proficiency in analytical techniques such as HPLC, GC, UV-Vis, FTIR, and wet chemistry methods.
- Strong understanding of cGMP, GLP, ISO 13485, and other relevant regulatory requirements.
- Demonstrated ability to troubleshoot analytical instrumentation and methods.
- Excellent data analysis, interpretation, and technical writing skills.
- Ability to work independently and as part of a team in a fast-paced, regulated environment.
- Meticulous attention to detail and strong organizational skills.
Preferred Qualifications
- Master's degree in Chemistry or a related field.
- Experience with method development and validation.
- Familiarity with LIMS systems and electronic data management.
- Experience with statistical process control (SPC) and quality tools.
- Proven track record of mentoring or training junior laboratory personnel.
Perks & Benefits
- Comprehensive medical, dental, and vision insurance plans.
- 401(k) retirement plan with company matching.
- Generous paid time off (PTO) and holiday schedule.
- Tuition reimbursement and professional development opportunities.
- Employee stock purchase program.
- On-site fitness center and wellness programs.
- Career progression pathways and mentorship programs.
- Competitive base salary with performance-based bonuses.
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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