Objective
Under general supervision, will sample and inspect a variety of incoming components for conformance to DenMat requirements.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
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Provide QC support for incoming inspection and Inspection and testing for designated production areas, i.e., Compounding, Filling, Final Assembly, Light Room, PeriOptix and Procare areas.
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Conduct scheduled and random inspection activities on rework activities, components, finished goods, kits and lights. Perform analytical and/or technical evaluations as required by inspection instruction.
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Sample in-coming component receipts according to current Sampling Plan and compares samples to corresponding specifications.
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Route samples of certain components to different departments for specialized inspections and approval. Where appropriate, communicates any special urgency that may exist to expedite inspection and release.
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Record clear, detailed results of evaluations, including acceptances, releases, rejections, or other.
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Immediately notifies pertinent departments in the event that inspections uncover any nonconformities that may affect production, inventory levels, etc.
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Provide product releases, where appropriate.
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Prepare and distribute nonconformance reports to Planning, Purchasing, and Quality Control to alert vendor and solicit corrective and preventative actions to prevent occurrences.
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Maintain specifications and standards so that in-coming materials are evaluated according to current requirements.
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Identify product (Componentry, finished goods, kits, lights etc.) status.
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Coordinate calibration efforts including the following packing and shipping, maintain equipment fields.
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Adhere to all company rules and regulations, including safety and work instructions.
Additional Duties and Responsibilities include the following. Other duties may be assigned.
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Other duties as assigned, i.e. cross train
Supervisory Responsibilities
This position has no supervisory responsibilities.
Education and/or Experience
High school diploma or general education degree (GED) and one year of experience in medical device quality control. Associates degree (AS) in life sciences from two-year college or technical school preferred.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the described functions.
Language Skills
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine notes, documentation, and complete forms accurately. Ability to effectively communicate information in one-on-one situations to other employees of the organization.
Mathematical Skills
Competence at working with fractions, percentages, ratios and proportions. Expanded knowledge of more advanced mathematics such as algebra and geometry. Basic understanding of statistics.
Computer Skills
Must be able to use word processing and spreadsheet applications. Must possess ability to learn various software programs.
Certificates, Licenses, Registrations
None required.
Knowledge, Skills, and Abilities
Knowledge of medical device manufacturing or related field.
Knowledge of current company products and processes.
Knowledge of laboratory practices, procedures and terminology.
Knowledge of proper sample handling, preservation and storage.
Skill in the proper use, maintenance and storage of lab equipment.
Ability to conduct routine tests and evaluate data against set specifications.
Ability to maintain accurate records.
Ability to demonstrate initiative and decision-making capability within company or departmental guidelines.
Ability to coordinate tasks while maintaining consistently high work quality and accurate documentation of laboratory work and related activities.
Ability to use laboratory equipment and test apparatus.
Ability to communicate effectively, orally and in writing, with employees of various disciplines and departments.
Ability to accurately perform detail-oriented work.
Ability to be flexible in changing daily workload priorities as directed.
Ability to function in a controlled environment under domestic and international regulations and handle extremely confidential data.
Physical Demands and Work Environment
The physical demands and work environment characteristics 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.
While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; stand; use one or both hands repetitively; use a simple/light, or firm grasp; grasp using one or both hands; use both hands with fine dexterity; and to lift and/or move up to 10 lbs. The employee is occasionally required to walk; talk and hear; grasp using one hand; push and/or pull; use fine dexterity with one hand; reach overhead; stoop, kneel, bend, or crouch; work around machinery and equipment, including moving mechanical parts; and lift and/or move up to 50 lbs.
While performing the duties of this job, the employee is occasionally exposed to dust, gas, fumes or airborne particles and required to wear protective equipment such as safety goggles, gloves, and face mask. Normal vision ability (20/20 with corrective lenses if necessary) is required for this position. Specific vision ability includes close vision and ability to adjust focus. The noise level in the work environment is usually moderate.
The posted range for this position is $38,741 - $53,270 annually which is the expected starting base salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay within the posted range including education, prior experience, training, current skills, certifications, location/labor market, internal equity, etc.
DenMat offers a complete benefits package, including medical/dental/vision/Rx, Life, 401(k) with matching, 10 paid company holidays, vacation and sick time, bereavement, EAP, and employee discounts.
DenMat participates in E-Verify.
DenMat Holdings, LLC is an Equal Opportunity/Affirmative Action Employer; employment with DenMat is governed on the basis of merit, competence and qualifications and will not be influenced in any manner by race, color, religion, creed, national origin/ethnicity, veteran status, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital status, or any other legally protected status.
