Quality Engineer – IQ/OQ/PQ validation

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 sboddy@provenrecruiting.com 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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