QC Inspector I

Overview

Aesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community. Through close collaboration with its customers, Aesculap provides advanced technologies for general surgery, neurosurgery and closure technologies. Aesculap continues a proud heritage of leadership and responsiveness as we strive to deliver products and services that improve the quality of patients’ lives.

Responsibilities

Position Summary:

Responsible for the inspection and disposition of medical devices. Documentation of the inspection activities and record keeping per relevant regulatory requirements and company policy.

Responsibilities: Essential Duties

• Follows directions from the Supervisor, Quality Control Inspectors prioritizing daily inspection activities for the department.
• Independently inspects medical devices to established standard operating procedures and product specifications.
• Complies with all relevant SOP’s and Work Instructions and properly documents activities when necessary.
• Uses SAP to record relevant inspection activities, run inventory reports, process complaints and returns.
• Works on special projects as assigned.
• Inspects in-house packaging, labeling and assembly operations according to established standard operating procedures (SOP’s) and product specifications.
• On a regular basis, work in returns inspecting and processing RGRs and complaints.
• Must comply with applicable ISO and FDA regulations as stated in Quality Manual.
• Work both independently and in a team to support KPI metrics.
• Work with other departments to support the receiving and shipping schedule.
• Ability to present job tasks to internal and external auditors.
• Proper records management both physically and electronically.
• Must embody the Company’s Vision, Mission and Values.
• Other duties may be assigned.

Expertise: Knowledge & Skills

Supervisory Responsibilities:

• Not Applicable

The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case.  The range provided is a reasonable estimate.

Target Based Range

Qualifications

Expertise: Qualifications-Experience/Training/Education/Etc

Required:

• Associate Degree in a related field is preferred or equivalent experience.
• 2 years Quality Control experience (surgical instrument experience) preferred.
• Must have understanding of Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP).
• Must have strong PC skills.
• 2 years of SAP experience preferred.
• Must be able to use general inspection equipment including micrometer, caliper, pin/block gages, optical comparator, and scales.
• Understanding of how to interpret drawings, specifications, artwork.
• Knowledge of sampling plans such as AQL preferred.
• Language and mathematical skills; reasoning ability:
• Language Skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
• Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
• Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

Desired:

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 50 pounds.

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Additional Information

Responsibilities: Other Duties:

The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

Physical Demands:

• The employee must occasionally lift and/or move up to 50 pounds.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment:

• This position could require the handling of instruments that may or may not have been contaminated by blood or other body fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

Referral Amount

Notices

Equal Opportunity Employer Veterans/Disabled

Salary : $20 - $24