Quality Engineer

Riverpoint Medical; Portland (OR); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Medical, Dental and Vision insurance

401(k) with company match

Paid Time Off

8 company paid holidays

Job summary

Riverpoint Medical in Portland, Oregon is seeking a Quality Engineer to join their team in delivering premium medical devices. The role involves overseeing quality assurance processes, managing complaint analysis, and ensuring regulatory compliance.

Ideal candidates will hold a BS in Engineering with at least 3 years of experience in the medical device industry. The position offers competitive benefits including health insurance, 401(k) with match, and paid time off.

Qualifications

• 3+ years of related experience in the medical device industry.
• Experience in an ISO13485 or FDA regulated environment is desirable.
• Ability to perform complaint analysis and product failure investigations.

Responsibilities

• Oversee the complaint handling process and perform analysis.
• Collaborate on Medical Device Reporting (MDR) requirements.
• Coordinate multiple quality management systems including CAPA.

Skills

Complaint analysis activities

CAPA planning

Failure Mode Effects Analysis (FMEA)

Technical writing

Computer skills (Word, Excel)

Education

BS in Engineering

MS in Engineering

Job description

Riverpoint Medical in Portland Oregon is looking to hire a Quality Engineer. At Riverpoint you will be part of the process that brings great technology to Medical, Dental and Veterinary markets. We specialize in the design and manufacturing of premium medical devices. Our ingenuity can be found in our suture technologies, sports medicine fibers and anchors, surgical lighting, and special needle technologies.

Duties and Responsibilities

• May provide oversight and ensure timely execution of the complaint handling process
• May responsible for all complaint analysis activities and trending.
• May collaborate with Regulatory on Medical Device Reporting (MDR) and adverse event reporting requirements
• Coordinate planning, implementation and trending of multiple quality management systems including CAPA, SCAR, and non-conformances.
• Perform internal and supplier audits
• Assist in the writing and execution of system validation plans
• Promote compliance to company procedures
• Support process validation studies for special processes and drive a reduction in Riverpoint Medical’s reliance on inspection/verification as a quality assurance methodology
• Develop and execute IQ, OQ and PQ protocols for product, processes, and equipment within the facility
• Write reports summarizing results and statistics for all equipment, product, or process validation projects. Assist production with equipment installation and maintenance
• Improve upon process controls related to Finished Device packaging, labelling and sterile product management, including aspects such as label reconciliation, segregation and material flow controls, and lot release activities
• Participate in the timely processing of complaints, non-conformity, returned materials and corrective actions
• Assist in investigations of incidents related to Riverpoint Medical products and appropriate reporting of such events to US and foreign regulatory authorities and notified bodies, as applicable
• Assist in QA/RA, production and product development personnel in formatting and compiling quality system documents

Education and Qualifications

• BS (engineering preferred) with 3+ years related experience in the medical device industry or MS engineering and 0+ years related experience, or equivalent experience
• Complaint analysis activities and product failure investigations desirable
• CAPA planning and implementation desirable
• Use of Failure Mode Effects Analysis (FMEA) desirable
• Work experience in an ISO13485 or FDA regulated environment desirable
• Computer skills, including Word and Excel
• Demonstrated technical writing skills

Benefits

We offer great benefits: Medical, Dental and Vision, Life and Accidental Death Insurance; 401(k) with company match and immediate vesting, Paid Time Off and 8 company paid holidays.

Riverpoint Medical is committed to a diverse and inclusive workplace. Riverpoint Medical is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.