Senior Quality Engineer
Nano Precision Medical, United States

This is an excellent opportunity for an individual with an explorative nature and a desire to apply both quality sciences and engineering into areas of noval healthcare technologies. This key position seeks a self-starter with experience from design development through commercially marketed product quality management systems compliance. The ideal candidate is one who seeks to apply safety and efficacy in harmony.

Requirements

Qualifications:

1. Education and Training

• A minimum BS in Engineering or a related scientific field or equivalent combination of training and experience

2. Required Experience

• A minimum of 8 years of relevant medical device and or pharmaceutical quality experience, preferably at least 2 years of start-up experience.
• Independent quality certifications a plus, but not required.

3. Essential Skills

• Must be able to maintain a quality system, including all types of QS document generation, calibration, audits, QC inspection, supplier qualification, process validation, and approved supplier management.
• Demonstrate a working knowledge of Design Controls (specific experience to 21 CFR 820 and ISO 13485) and the Product Development Process
• Must have a thorough working knowledge of new product development, process capability, and process validation. Must be able to author, execute, and finalize qualification/validation projects and documentation.
• Must be able to implement, understand, and manage CAPA, Design Control, DMAIC, FMECA, SPC, DOE, validation; New Product Development, Root Cause Analysis, and statistical techniques.
• Should possess pre-human use experience, be able to generate protocols, help execute studies and collect all related documentation, including working with the study facility to generate related reports.
• Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with team members and management to develop robust policies and procedures.

• Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes.

4. Personal Attributes

• Self-starter
• Strong collaborator
• Comfortable with multi-tasking

5. Other Requirements

• Experience with designing, planning, and executing experiments
• Experience managing multiple fast-paced projects
• Comfortable working with junior engineers and scientists
• Excellent communication and documentation skills

• Legally eligible to work in the US

Benefits

• Work in a collaborative, learning environment with cutting edge technology, research and development
• Flexible scheduling and generous perks
• Medical, Dental, Vision coverage and 401k

Job Rewards and Benefits