The QC Technician I is responsible for 100% review of all documentation records for accuracy, completeness and be a support function for production teams and perform daily product inspections. This position will also assist in the releasing of sterilized devices, and complete review of sterilizations reports. QC Technician I will be responsible for incoming inspection and ensure that all products received meets all incoming inspection criteria and release conforming product.
Knowledgeable in all aspects of 1+ areas, and is qualified in assigned areas while building expertise in other areas. Occasionally flexes to other areas but needs direction and/or supervision. Drive #CABOS culture daily by actively collaborating with quality and manufacturing teams.
Essential Duties and Responsibilities
- Initiate correction request for discrepancies pertaining to DHR records, Times, Temperatures, documentation error, Quantity, etc.
- Maintain spreadsheets for track and trend analysis (Samples, GDP, inspections, findings, etc.) Prepares basic/simple technical reports.
- Maintain Good Record- keeping practices.
- Responsible for accurate and organized maintenance of quality records.
- Good communication with the organization to ensure actions are taken to resolve corrections needed.
- Verifies documentation (PO, Certificate of Analysis, Certificate of Compliance, MSDS, etc.) is present.
- Completes all daily monitoring forms ( Seal sample, product inspections, etc.) as required by procedure
- Inspects material using various measuring tools, uses AQL requirements to specific drawling’s and required documents per procedure to ensure the correct material has been received.
- Maintains quarantine cage in accordance to SOP.
- Completes all documentation related to Non-conforming material.
- Ability to create, investigate and sustain Non-conformance’s.
- Maintains accurate records.
- Ability to communicate findings effectively in oral and written form with the aim of improving process concerns with the use of sentinel requirements.
- Perform quality control/release testing on products and incoming quality inspections and test of raw materials as directed.
- Precise and meticulous in observing and recording all details of daily processing including: volume, lot numbers, colors, particles, and any deviations from procedure.
- Draft/revise Quality Control procedures and SOP with engineering/R&D support.
- Suggests and documents process changes to support projects and process improvements.
- Liaison for quality assurance, engineering and development groups for all manufacturing issues.
- Drives #CABOS culture and has the ability to work as a team by collaborating with quality and manufacturing teams.
- Ability to perform UDI scanning as part of FDA requirement.
- Ability to problem solve and addresses production related concerns.
- Address compliant request by providing production related documents/additional inspection request may be required.
- Adhere to ISO13485.2016 requirements.
- Works under supervision
- Receives detailed instructions for process
- Other Duties as assigned by manager.
Qualifications (Education, Certifications and/or Experience)
- High School or equivalent.
- Excellent oral and written communications skills.
- Minimum one year experience working in a regulated environment.
- Ability to work independently with little direction.
- Ability to follow and meet schedules and timelines.
- Ability to work varied schedules and overtime hours as necessary.
- Understand and follows QSR, ISO, and departmental procedures.
- Experience in Microsoft Office (word, excel, etc.).
- Experience with JD Edwards preferred.
- Exposure to a medically controlled environment, subject to interruptions, subject to changing conditions.
- Protective Personal Equipment required as indicated by area procedure.
- Physical Requirements: prolonged standing, sitting, and/or walking. This position may also require: hands to finger motion, handling, reaching with hands and arms, balance, stooping, kneeling, or crouching.
- Medium Work: Will occasionally need to lift and/or move up to 30 pounds (see assistance for greater amounts)
- Visual Demands: Near acuity; ability to see at 20 inches or more, distance vision, peripheral vision, depth perception, and the ability to adjust focus.
Work From Home: No
Travel Percentage: 0%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.
Stryker is an EO employer – M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
To apply for this job please visit stryker.wd1.myworkdayjobs.com.