Job Description

The Operations Quality Technician will be a critical contributor in a mission that truly represents a once-in-a-lifetime opportunity to join a company that is making significant investments in establishing US manufacturing, expanding internationally, and delivering a consistent cadence of product innovations to the market and investing in its people.

The successful candidate will be responsible for ensuring our manufacturing site produces and distributes products which meet or exceed all established quality standards and will be responsible for ensuring our processes and procedures are compliant with corporate policies and federal law. The individual will be trained in performing Incoming, In-process inspections in the cleanroom, or assessing the final product’s efficacy prior to market release. In addition to those activities, this position may also be required to support production operations, metrology, microbiology, or other manufacturing functions as business needs arise. This position requires a strong attention to detail, problem solving skills, and willingness to work in a fast-paced manufacturing environment.

Responsibilities:

• Inspect and record results of work on Incoming raw material, In-process, or Lot Qualification at various stages of the production process, distribution process to determine and maintain the quality and reliability of our product.

• Assess and complete inspection reports and records including the entry of data into various electronic systems. (For example – Word, Excel, SAP, Electronic DHR systems, Oracle Agile, and others).

• Generate, review, and maintain quality records in support of the Quality System. (For example – device history records and training records)

• Ensure the equipment calibration status is within the timeframe of use.

• Assist the Quality Manager in notified body and regulatory authority audits and inspections.

• Works from specifications, work plans, procedures, and general instructions from either Quality Engineers, Quality Supervisor, or the Quality Manager.

• Required to maintain and enforce cGMPs.

• Safely follow standard operating procedures including but not limited to quality standards, material handling, and record keeping. Must follow all Good Manufacturing Practices (GMPs), Good Documentation Practices (GDPs), and Good Laboratory Practices (GLPs).

• Notifies Quality or Operations Leadership of any discrepancies to ensure quality standards and safety of operations are maintained at all times.

• Maintain a clean work environment suitable for medical device manufacturing and cleanroom production.

• Performs other duties as required

Education and Experience:

• High School diploma

Required Core Competencies:

• Excels at the organization and maintenance records accurately. 

• Self-starter capable of dealing with a variety of tasks in a fast paced, multi-tasking environment.

• Must be proficient in English language to be able to read documentation, communicate, and write.

• Mathematics – Basic mathematics skills (adding, subtracting, multiplying, dividing)

• Autonomy - Capable of working independently with minimal instruction from their supervisor.

• Familiarity with measurement instrumentation such as micrometers, calipers, tensile testers, video microscopes, and optical gauging products preferred, not required.

• Experience working in a lab setting environment in the medical device industry preferred, but not required.

• The ability to use stereoscopes and varying microscope setups preferred, but not required.

Physical Requirements:

• Required to stand for at least 75% of working time per shift, with walking at least 50% of working time per shift.

• Required to reach above shoulder frequently and below waist occasionally.

• Required to push and pull.

• Ability to lift up to 50lbs occasionally, 5-20lbs frequently.

• Vision capability to inspect smallparts/components/labeling(Corrective lenses allowed)

*Would like to add a test component to ensure that candidates can successfully utilize the microscopes from a vision perspective.

NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite

Additional Information:

The US base salary range for this full-time position is $19.00 - $28.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.