Quality Control Inspector

BPI Medical; Fife (WA); On-site; USD 42,000 - 66,000; Full time

Job summary

BPI Medical is seeking a Quality Control Inspector to inspect incoming materials, components and finished medical devices. You will document results and ensure compliance with regulatory standards while working with cross-functional teams to drive continuous improvement.

The role requires independent work, adherence to procedures, and collaboration with production staff to uphold quality and delivery targets. E-Verify participation is a stated company practice.

Qualifications

• Experience performing quality inspections and recording results.
• Familiarity with regulatory standards for medical devices (e.g., ISO 13485, FDA).
• Ability to work independently and follow established procedures.

Responsibilities

• Conduct inspections and tests on raw materials, components, and finished products to ensure quality standards.
• Perform visual, dimensional, and functional tests on medical devices per regulations.
• Document inspection results and maintain regulatory records.
• Identify non-conformities and report for investigation and corrective action.
• Participate in root-cause investigations and CAPA implementation.

Skills

Quality inspection

Documentation

Regulatory compliance

Cross-functional collaboration

Problem solving

Tools

Micrometers

Calipers

Fixed gauges

Optical comparator

CMM

Job description

BPI Medical is growing at a remarkable rate and offers a rewarding career for a proven leader interested in making a difference every day. We embrace our entrepreneurial culture and have created a workplace where collaboration is essential, courage is rewarded, speed is expected, and agility is the norm to meet our customer's needs.

Our motto is \"Its gotta be right. its gotta be fast. no exceptions.\" We live by our values of Integrity, Quality, On-time Delivery, Collaboration, Growth Mindset and Compassion. We have a relaxed work atmosphere with an exceptional staff. We understand that continuous improvement is more than a business philosophy. It's a personal contribution to making our customers, our business, and our team members better every day.

This position will engage in quality control activities designed to inspect, measure, and verify the effectiveness, and adherence to medical industry quality standards. The position is expected to work independently with the ability to exercise sound judgment, following established processes and procedures that govern quality control inspection.

• Conducting inspections and tests on incoming raw materials, components, and finished products to ensure they meet established quality standards and specifications.
• Performing visual inspections, measurements, and functional tests on medical devices to verify their compliance with applicable regulations and standards, such as ISO 13485 and FDA guidelines.
• Documenting inspection results and maintaining accurate records of quality control activities in accordance with regulatory requirements.
• Proficient in the use of mechanical inspection equipment; including micrometers, calipers, fixed gauges, optical comparator, CMM and other inspection measuring tools.
• Identifying and reporting non-conformities or deviations to appropriate personnel for investigation and corrective action.
• Participating in investigations of quality issues and working with cross-functional teams to determine root cause and implement corrective and preventive actions.
• Ensuring that inspection equipment and tools are calibrated and maintained in accordance with regulatory requirements and company procedures.
• Developing and implementing quality control procedures and work instructions to ensure consistent product quality.
• Collaborating with production staff and other stakeholders to address quality issues and drive continuous improvement.
• Participating in internal and external quality audits to ensure compliance with applicable regulations and standards.
• Communicating effectively with customers, suppliers, and other stakeholders on quality-related matters, including product quality, regulatory compliance, and quality system requirements.

We are proud to be an Equal Opportunity Employer. BPI Medical, also known as Ben's Precision Instruments, was founded by a machinist-craftsman from Holland. Ben Overmars Sr. is both an immigrant and a worker performing fully with a disability. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

As a federal contractor, BPI Medical is required to participate in the federal government's E-Verify program. With E-Verify we are able to confirm the employment authorization of all newly hired employees and most existing employees through an electronic database maintained by the Social Security Administration and Department of Homeland Security.