Quality Control Inspector

bpimedical; Fife (WA); On-site; USD 55,000 - 75,000; Full time

Job summary

BPI Medical is seeking a Quality Control Inspector in Washington to join a fast-moving, quality-focused team. You will inspect raw materials, components, and finished devices to verify compliance with ISO 13485, FDA guidelines, and internal specs.

You will document results, maintain calibration records for micrometers, calipers, gauges, and CMMs, participate in investigations and audits, and collaborate with production to drive continuous improvement and regulatory compliance.

Qualifications

• Experience conducting inspections and tests to ensure quality.
• Ability to develop and follow QC procedures.
• Strong documentation and regulatory record-keeping.

Responsibilities

• Conduct inspections and tests on incoming raw materials, components, and finished products to ensure quality.
• Perform visual inspections, measurements, and functional tests on medical devices to verify regulatory compliance.
• Document inspection results and maintain records per regulatory requirements.
• Identify non-conformities and report for investigation and corrective action.
• Participate in investigations and root-cause analysis with cross-functional teams.
• Ensure inspection equipment calibration and maintenance per procedures.
• Develop and implement quality control procedures and work instructions.
• Collaborate with production staff to address quality issues and drive improvements.
• Participate in internal and external quality audits.
• Communicate with customers, suppliers on quality-related matters.

Skills

Mechanical inspection proficiency

ISO 13485 & FDA guideline familiarity

Tools

Micrometers

Calipers

Fixed gauges

Optical comparator

CMM

Job description

Overview

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.

Responsibilities

• 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.

Compliance and Equal Opportunity

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.