Job Specific Requirements

Quality Assurance

• Working knowledge of / assisting in compliance with ISO 13485:2016, MDSAP, and other applicable requirements throughout all departmental functions.
• Provides support for all departmental processes/objectives by facilitating coordination across departments and external parties in the execution of daily organizational functions under direction of Management team.
• Assists in the execution of regular departmental functions, including but not limited to: Document control, ongoing QMS maintenance, training, nonconforming material (NCRs), corrective and preventive action (CAPAs), complaint handling, and validation & equipment management.
• Provide support on audits (internal and external) of the quality management system and processes.

Document Control

• Maintains complete and current archives of all quality records.
• Initiates new change orders, ensuring the appropriate approval and training requirements are documented and executed.
• Ensure that all change order implementation activities are completed and appropriately documented.

Training & Resources

• Ensure that training is performed and documented. Maintain the training matrix and use to create and update job descriptions.

Nonconforming Material (NCR), Corrective and Preventive Action (CAPA), Complaint Handling

• Assist in making the determination when a new NCR, CAPA, or complaint should be generated
• Initiate NCRs, CAPAs, and complaint records. Analyze and document the reportability determination of potential adverse events.
• Ensure timeliness of executing record activities and on-time closure.

Measuring Devices and Equipment

• Confirm all equipment is identified and maintenance/calibration remain current. All QMS forms are completed and on file.

Education and Experience

• Bachelor’s Degree in job related field or equivalent professional experience.
• Effective communications skills, including technical writing, professionalism, and responsiveness.
• Experience in a medical device or related field preferred.

Personal Attributes

• Self-motivated
• Attention to detail
• Dependable
• Ethical
• Fast learner

Job Type: Full-time

Pay: $50,000.00 - $65,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Work setting:

• In-person

COVID-19 considerations:
Masks recommended. Regular cleaning and sanitization.

Ability to commute/relocate:

• Lake Oswego, OR 97035: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• Why are you interested in this position / what are you looking for in your next role?

Education:

• Bachelor's (Preferred)

Experience:

• Quality / Regulatory: 1 year (Preferred)

Work Location: In person

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