Engineer, Quality

Education

Experience

Preferred Qualifications

• ASQ Certified Quality Engineer (CQE) or similar certification.
• Experience with regulatory submissions (510(k), CE Marking) is a plus.
• Experience with eQMS systems (e.g., MasterControl).
• Experience with risk management (ISO 14971) and validation activities.

Minimum Requirements/Qualifications

• Working knowledge of current FDA, ISO 13485, CMDR and TGA medical device regulations.
• Ability to respond to internal and external quality audits and perform root cause analysis and risk assessment activities.
• Proficiency with Microsoft Office software (e.g. Microsoft Word, PowerPoint, Excel).
• Excellent technical writing and organizational skills.
• Familiarity with design controls and product lifecycle management.
• Strong analytical, problem-solving, and communication skills, both written and verbal, to clearly and concisely communicate to all levels of the organization.
• Strong work ethic and an ability to excel within a rapidly changing and growing organization.
• Thrives in a fast-paced, collaborative environment, efficiently works under pressure, within deadlines or other time essential constraints.
• What We Offer:
• Salary Range: $70,0000-$85,000, depending on location, experience, and qualifications.
• Benefits coverage begins day one, including the following: Medical, Dental, Vision Insurance Disability Insurance Life Insurance 401(k) company match Paid Time Off (15 days annually) Paid Holiday time (10 company-designated days) Tuition Assistance Additional benefits available with company package
• Medical, Dental, Vision Insurance
• Disability Insurance
• Life Insurance
• 401(k) company match
• Paid Time Off (15 days annually)
• Paid Holiday time (10 company-designated days)
• Tuition Assistance
• Additional benefits available with company package
• This position has not been approved for Relocation Assistance.
• The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not an exhaustive list of all of the duties and responsibilities associated with it.
• All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.