Principal QC Specialist, Medical Devices

Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche's commercial portfolio & pipeline products. The Quality Control organization at HTO comprises approximately 50 employees organized in five departments and is a central key point for the manufacturing of high quality medicines. Together, we produce life-saving medicine every year to patients around the world.

The opportunity:

Are you looking to join a team that drives positive change? The HTO Quality Control (QC) team is looking forward to investing in the rising demand of medical device testing which will be addressed by a this new role of Principal QC Specialist, Medical Devices. You will work closely with QC Operations, QC Support Teams, QC Leaders and other site functions with strategic guidance with regards to medical devices for the safety of our products and for the health of patients.

• You will be a ember of the QC Direct Material team

• You will assess the current status of medical device testing and establish strategy to comply with upcoming testing needs

• You will drive improvements in the medical device testing sector

• You will ensure a good flow of information within and outside your own organizational area.

• You will develop, implement and execute QC strategies and goals with local as well as global partners

• You will represent QC Material Testing & Medical Devices in audits and inspections; Ensure procedures and documentation are regulatory compliant and inspection ready.

Who You Are

• You hold a Bachelor's of Science degree with 8-11 years of dynamic experience in the pharmaceutical or scientific industry.

• You have significant experience working in a cGMP or similarly regulated environment and within the medical device area and extensive knowledge of the current medical device regulations

• You possess a deep understanding of QC practices, regulations, and industry guidelines and consistently apply this understanding when performing your tasks.

• You have the judgment / discretion to advance matters of significance, ensuring efficient testing operations and regulatory compliance.

• You possess outstanding social skills and strong written and verbal communication skills. You use these skills to build effective multi-functional teams and commit to timely informed decisions and completion of simple to moderate actions from others.

• You are able to build trusting and effective relationships with a wide range of partners at the Hillsboro site and in the global Roche network.

• You have a passion and ability for mentoring and encouraging others and are able to build/ maintain effective multi-functional teams without direct management responsibilities.

• You will be working on site in a flexible open space work environment with random visits to a QC laboratory environment that requires laboratory gowning (lab coat, goggles, gloves)

• You may be required to lift up to 25lbs

• You may have to work with hazardous materials and chemicals.

The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $90,200 - $167,310. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Please note this role is eligible for relocation benefits.

Link to Roche/Genentech Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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