Pharmavise Corporation

Quality Engineer II — Medical Device (Onsite — Valencia, CA) Possible Contract Extension

Pharmavise Corporation  •  Valencia, CA (Onsite)  •  1 month ago
Apply
AI can make mistakes so check important info. Chat history is never stored.

Job Description


Job Summary:


Responsible for creating test methods, work instructions,

training

and mentoring technicians who work on investigation of return and not-return products. The QE will review

result

of investigations completed by others for accuracy,

completeness

and compliance

to

SOPs/

WIs.

The results of investigations can be used to escalate product issues in collaboration with other Post Market functions, R&D, Design Assurance, Operations, Supplier Management, and Medical Safety.


Responsibilities will include:


  • Understanding failure modes and approving product analysis for return and non-return complaints related to mechanical medical devices performed by technicians


  • Coordinating, training and supervising failure investigation activities for lab technicians


  • Support integration of new products into CIS lab by creating/

    validating

    test methods and test instructions


  • Creating and presenting slides for SER/CRB


  • Collaborating with other Post Market (CCC/CMC) teams, R&D, Design Assurance, Manufacturing, Supplier to help

    determine

    root cause of complaints


  • Monitoring

    product performance and escalating any non-conformance issues with returned device.


  • Creating, releasing new WI/SOPs in document control system


  • Initiating and owning non-conformance investigations


  • Training technicians to find root cause of complaints through sound failure analysis techniques


Minimum Qualifications:


  • Bachelor’s degree in Mechanical Engineering

    with 2+ years of relevant experience ***

    Bachelor's

    degree can be in electromechanical/

    electrical

    but the candidate needs to have hands-on experience in failure analysis.


  • Demonstrated

    problem-solving & failure analysis capabilities of mechanical systems/components


  • Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook


  • Great written/verbal communication skills and ability to collaborate with other teams


  • Ability to successfully multi-task and be adaptive


Preferred Qualifications:


  • Masters

    degree in Mechanical Engineering with at least 1 year experience in similar role


  • Ability to understand system level functionalities, to devise and

    validate

    test methods for failure analysis of systems/components


  • Experience in Medical Device industry


  • Familiarity with Post Market requirements and systems


  • Familiarity complaint systems used for medical devices


  • Experience with using SAP and

    PowerBI


Other Details:


Schedule: 08:00:AM - 04:30:PM


Work Setup: Onsite in

Valencia, CA


Contract Length: 12 Months (

5/25/2026 - 5/25/2027

) and

Possible

Extension

Pharmavise Corporation

About Pharmavise Corporation

♦𝐄𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐜𝐞 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐐𝐮𝐚𝐥𝐢𝐭𝐲♦: 𝐏𝐡𝐚𝐫𝐦𝐚𝐯𝐢𝐬𝐞, 𝐲𝐨𝐮𝐫 𝐬𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐋𝐢𝐟𝐞 𝐒𝐜𝐢𝐞𝐧𝐜𝐞𝐬, 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐚𝐧𝐝 𝐆𝐨𝐯𝐞𝐫𝐧𝐦𝐞𝐧𝐭 𝐬𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬 𝐩𝐚𝐫𝐭𝐧𝐞𝐫.

𝗔𝗯𝗼𝘂𝘁 𝘂𝘀 𝗜𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻:

We provide high-quality, cost-effective people and process solutions for your Quality, Regulatory, Engineering, Clinical, and Healthcare needs. Our company mantra 𝐄𝐗𝐂𝐄𝐋𝐋𝐄𝐍𝐂𝐄 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐐𝐔𝐀𝐋𝐈𝐓𝐘. The safety and quality of the drugs and devices produced for patients are directly related to 2 things, 𝐑𝐎𝐁𝐔𝐒𝐓 𝐏𝐑𝐎𝐂𝐄𝐒𝐒 𝐚𝐧𝐝 𝐐𝐔𝐀𝐋𝐈𝐅𝐈𝐄𝐃 𝐏𝐄𝐎𝐏𝐋𝐄. 𝐖𝐞 𝐝𝐞𝐥𝐢𝐯𝐞𝐫 𝐛𝐨𝐭𝐡.

𝐃𝐢𝐟𝐟𝐞𝐫𝐞𝐧𝐭𝐢𝐚𝐭𝐨𝐫𝐬:

☑𝐇𝐢𝐠𝐡𝐥𝐲 𝐒𝐤𝐢𝐥𝐥𝐞𝐝 𝐓𝐞𝐚𝐦: Our team of experienced consultants with distinct backgrounds in life sciences, including scientists, researchers, and regulatory experts. The quality and expertise of our team significantly impact our client’s success.

☑𝐒𝐩𝐞𝐜𝐢𝐚𝐥𝐢𝐳𝐞𝐝 𝐄𝐱𝐩𝐞𝐫𝐭𝐢𝐬𝐞: We focus on specific niches within the life sciences, healthcare, and government sectors, such as pharmaceuticals, biotechnology, medical devices, regulatory affairs, medical research, and product development. This specialized expertise allows us to offer targeted and in-depth insights to our clients.

☑𝐂𝐮𝐬𝐭𝐨𝐦𝐢𝐳𝐞𝐝 𝐒𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬: We offer tailored solutions that align with the specific requirements of each client, rather than one-size-fits-all approaches, demonstrating a commitment to meeting client needs. We do not require a long learning curve, which leads to a faster payback and a greater return on your investment.

𝗣𝗲𝗿𝗳𝗼𝗿𝗺𝗮𝗻𝗰𝗲 𝗛𝗶𝘀𝘁𝗼𝗿𝘆

Over 20 Technical Transfers and 30 product launches.

11 FDA remediations. Warning Letters and or Consent Decrees.

Cost savings and increased efficiency of over 10MM for clients

Industry
Consulting & Advisory
Company Size
11-50 employees
Headquarters
Fort Lauderdale, Florida
Year Founded
2013
Social Media