Quality Engineer – IQ/OQ/PQ validation
San Diego, CA
Quality Engineer – IQ/OQ/PQ Equipment Validation
Startup culture, flexible hours, and a highly supportive team: this rapidly growing medical device company is looking for someone with a go-getter attitude who can bring strong Quality Engineering and Process validation (IQ/OQ/PQ) knowledge experience to the table, and in return they’re offering opportunities to grow and lead in an exciting, fast-paced environment. Ample opportunity for growth and skill development.
Who you are
- Bachelor’s degree in mechanical engineering, chemical engineering, biomedical engineering, and/or other engineering related degree
Minimum of 5-7 years medical device experience or similarly regulated ISO or cGMP/GLP environment is required.
Proven record creating and supporting validations and qualifications (e.g., Process validation, IQ, OQ, PQ) and compliance of regulated products is required.
Proven record creating and supporting risk management file maintenance (e.g., PFMEA, DFMEA, Risk File) is required.
Experience in conducting complaint/CAPA investigations.
What You'll Do:
Develop and implement quality test procedures, including the design of tests, testing mechanisms and test equipment.
Develop and execute test equipment IQ/OQ/PQ protocols and reports.
Conduct test method qualifications and validations, including qualifications, revalidation, and overall validation schedule/plan. Develop gauge reliability and repeatability studies for test and production-related equipment. Develop equipment calibration procedures.
Develop sampling plans for incoming materials and in-process and finished product testing based on appropriate statistical methods.
Responsible for product related investigations and corrective actions.
Maintain a working relationship with suppliers to ensure resolution of supplier-critical issues and investigations. This may include supplier visits to technically assist in the resolution of issues and investigations.
Why work here:
- Mentorship culture where you can learn new skills, maximize your growth, and leverage the knowledge of superiors.
- Small team environment encourages interdivisional collaboration. You’ll always have your voice heard and can wear many hats!
- Impact: Have a positive influence both as part of a lean team where your voice can be heard, as well as on the company as a whole.
What does this position pay?
Compensation is determined by several factors which may include skillset, experience level, and geographic location.
The expected range for this role is $85,000 to $120,000 per year.
Please note this range is an estimate and actual pay may vary based on
qualifications and experience.
Please email your resume to firstname.lastname@example.org if you’d like to work alongside some of the finest scientists in the pharmaceutical industry!
Note: We actively support and promote people of various backgrounds, from race, religion, gender to geographical area, university, lifestyle, and personality type. Proven Recruiting is minority-owned, majority women, and is a strong advocate for diversity and inclusion in the broader community. Apply today!
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