Sr. Quality Engineer

Sr Quality Engineer – Houston, TX

If culture and mentorship are your priorities – you’ve found your match. This pioneer company in Medical Device is looking to support and promote a talented Sr. Quality Engineer who will support design development activities for medical device technologies. The ideal professional will have experience working under ISO 13485 and ISO 60601, design controls from input through post market, class II medical device experience, as well as eagerness to join and contribute to a tight knit, mutually supportive community of skilled experts.

What you’ll do

• Lead design control activities including design reviews, customer requirement and product requirement creation, design verification and validation, and creation / management of the Design History File (DHF).
• Oversee ISO 60601 electrical safety testing and validation, ensuring compliance throughout product development.
• Ensure that our devices meet all regulatory and industry-specific standards, including FDA, ISO 13485, ISO 60601, ISO 14971, IEC 62304, and others.
• Develop, implement, and manage quality control processes specific to guidewires and robotic systems.

Who you are

• Bachelor’s Degree in Engineering or related field and 5-7 yrs of experienced with Class II/III Medical Device
• Proficient knowledge of medical device regulations, including FDA QSR, ISO 13485, ISO 60601, and IEC 62304.
• Experience with electro-mechanical medical device design & development activities

Why work here

• Supportive leadership & team: you’ll work with an intelligent, productive, appreciated and supportive team who enjoy and has a reputation for mentoring and developing others with a drive for success.
• Competitive package: this role offers base, bonus, equity, and benefits.
• High-growth environment: this company is rapidly expanding and is looking for people who can grow with them.

This role is 100% in office in Houston, TX and does offer a relocation package. 

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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 $110,000 to $140,000 per year. Please note this range is an estimate and actual pay may vary based on qualifications and experience.