Quality Engineering Technician

SMC Ltd; Santa Rosa (CA); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

401(k) retirement savings

Promotional opportunities

Training and career growth

Job summary

SMC Ltd. in Santa Rosa, CA is seeking a Quality Assurance Documentation Specialist to support validation cage materials, retain-sample controls, data-package review, CAR/CAPA containment, DHR reviews, and complaint investigations.

This role maintains material status, segregation, traceability, and records under Quality leadership. Responsibilities include ensuring documentation accuracy, updating templates, and routing issues for approval, with focus on controlled processes and English-language

Qualifications

• Associate or bachelor’s degree in quality, engineering, life sciences, manufacturing, or a related field.
• Alternatively, a high school diploma with 2–3 years of Quality Assurance experience is required.
• Working knowledge of controlled documentation and quality records review.

Responsibilities

• Manage validation cage material status and traceability with documented QA authorization.
• Maintain retain-sample controls and ensure proper logging, organization, and disposal per procedures.
• Review data packages for completeness, accuracy, traceability, and approvals; update templates and route discrepancies.
• Perform product containment activities for CARs and CAPAs, including locating and controlling affected product.
• Collaborate with Quality Engineers to draft, redline, and update inspection instructions and ensure compliance with current practices.

Skills

Quality Assurance

Documentation control

Communication

Education

Associate or Bachelor's degree in quality, engineering, life sciences, manufacturing, or related field

High school diploma + 2-3 years QA experience

Tools

Excel

Word

Outlook

Job description

About Us:

SMC Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people.

About Us:

SMC Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people.

Job Summary:

This position provides focused quality-system and documentation support for validation-cage materials, retain-sample controls, data-package and template review, CAR/CAPA product containment and related containment actions, inspection-instruction updates, and DHR reviews to support complaint investigations or shipment release. Working under the direction of designated Quality leadership and within delegated authority, the individual in this role maintains accurate material status, segregation, traceability, and records; identifies documentation gaps; and routes issues and required approvals to the appropriate Quality representative.

Essential Job Duties and Responsibilities:

• Manage the validation cage by maintaining accurate material status and traceability. Release or move material only with documented authorization from Quality Engineers (QEs).
• Maintain retain-sample controls by accurately logging, organizing, retrieving, and disposing of retained product in accordance with approved procedures and retention requirements.
• Review quality data packages for completeness, accuracy, traceability, required records, and approvals against the applicable approved template. Prepare data-package documentation, maintain and update data-package templates through the controlled-document process, and route discrepancies for correction.
• Perform and document product-containment activities associated with CARs and CAPAs, including identifying, locating, segregating, and controlling affected product.
• Collaborate with QEs to draft, redline, and update inspection instructions to reflect approved requirements and current practices.
• Review device history records (DHRs) for completeness, legibility, accuracy, traceability, required entries, and approvals to support complaint investigations or shipment release.
• Analyze data generated by Quality Technicians before sharing it with Quality Engineers.
• Collaboration with Training Quality Inspectors

Essential Qualifications:

• An associate or bachelor’s degree in quality, engineering, life sciences, manufacturing, or a related field.
• Alternatively, a high school diploma or equivalent, together with at least 2–3 years of Quality Assurance experience, is required.
• Working knowledge of good documentation practices and the ability to review quality records, data packages, documentation, DHRs, inspection instructions, and CAR/CAPA containment documentation for completeness, accuracy, and traceability.
• Ability to maintain controlled material and records, including validation-cage inventory, retain samples, containment status, and authorized release documentation.
• Strong attention to detail, organization, and follow-through, with the ability to manage priorities, communicate status clearly, and promptly escalation missing, unclear, or overdue information.
• Proficiency in Microsoft Excel, Word, and Outlook, and the ability to follow approved procedures, document-control requirements, and written and oral instructions in English.

Desirable Qualifications:

• Experience in medical-device manufacturing or another regulated manufacturing environment, and familiarity with ISO 13485, FDA quality-system requirements, and good documentation practices.
• Experience reviewing data packages and DHRs, and maintaining MRB lists, validation-cage materials, retain samples, CAR/CAPA containment records, and inspection instructions.
• Experience with electronic quality systems, document-control workflows, inventory or status logs, and controlled templates.

ADA Requirements:

• Medium work: Exerting up to 50 pounds of force occasionally and/or up to 20 pounds of force frequently and/or up to 10 pounds of force constantly to move objects.
• Stooping, kneeling, crouching, reaching, standing, walking, pushing, pulling, lifting, fingering, grasping, feeling, talking, and hearing.
• Ability to work for extended periods while sitting and looking at a computer, and to perform repetitive motions involving substantial movements of the wrists, hands, and/or fingers.
• Close visual acuity to perform activities such as preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visually inspecting small defects or small parts and/or operating machines (including inspection); using measurement devices; and/or assembling or fabricating parts at distances close to the eyes.
• Visual acuity to perform activities such as operating machines, including lathes, drill presses, power saws, and mills, where the visual task is at or within arm’s reach; and performing non-repetitive mechanical or skilled-trade tasks, such as those performed by carpenters, technicians, service personnel, plumbers, painters, and mechanics.
• Visual acuity to operate motor vehicles or heavy equipment.
• Visual acuity to determine the accuracy, neatness, and thoroughness of assigned work (e.g., custodial work, food services, and general labor), or to make general observations of facilities or structures (e.g., security and inspection).
• Subject to indoor environmental conditions: protected from weather conditions, but not necessarily from temperature changes.
• Subject to hazards, including proximity to moving mechanical parts, moving vehicles, electrical current, work on scaffolding and at heights, high heat, or chemicals.
• Subject to oils: exposure to oils and other cutting fluids through the air and/or skin contact.

What does SMC has to offer?

• Clean, Climate-Controlled Environment
• Stable schedule
• Paid holiday and PTO
• Health, dental, and vision insurance
• 401(k) retirement savings
• Life and disability insurance
• Promotional opportunities
• Training and career growth programs
• Amazing co-workers
• Tuition reimbursement
• Employee Assistance Program

We are committed to fair and equitable hiring with salaries based on relevant factors, such as work experience, education, and certifications. Toward the principle of equal pay for equal work, we post and hire within defined salary ranges. We ask all applicants to review salary ranges for each posted job opportunity, as we will not hire outside the predetermined range.

At SMC Ltd. we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodation during the interview process.

All applicants must be authorized to work in the US

SMC Ltd. is an equal opportunity employer. M/F/D/V; this organization uses E-Verify.

Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.

#IND