QA Compliance Specialist I/II

WORK SHIFT:

JOB DESCRIPTION:

The QA Compliance Specialist reporting to the Quality Systems Manager requires the individual to address inquires in

the following areas: Regulatory Compliance (NSF, FDA, European Union and Health Canada), Control Document

Management, Material Compliance as well as Internal and External Audit Compliance. The function will provide support

to our internal and external customers as well as serve as a liaison of Cambro product compliance to various levels of

management.

Administer and maintain NSF listings for Cambro domestically and internationally

* Train Cambro employees on all quality regulatory agency requirements of applicable guidelines to ensure compliance

* NSF inquiry and project submission process

* Investigate and review NSF non-conformances

* Communicate and maintain regulatory requirements as set forth by US and International agencies including

Federal Drug Administration, European Union and Health Canada

* Prepare, review and submit required reports to regulatory agencies and customers

* Serve as a resource by researching and providing information on product related inquiries to Legal Counsel to

resolve issues related to regulatory compliance requirements

* Conduct audits of products and processes as they relate to NSF and ISO standards.

* Work with internal departments to ensure implementation, maintenance, and improvement of the Quality

Management System

* Review, revise, and maintain the Controlled Document database

* Maintain working knowledge of ISO 9001 standards

* Assists New Product Development Department with documents needed throughout the development phases of the

product

* Must communicate with all levels of the organization relating to product and quality related updates

* Receive, evaluate, investigate, and respond to customer complaints and inquiries relating to Cambro product

(QAR)

* Ensures that customer receive product in a timely manner as a result of QARs

* Serve as primary contact during the absence of the Quality Systems Manager

* Gathers and enters data for weekly MOS reporting for the department

* Works independently and makes decisions based on experience and judgment in order to accomplish department

goals

* Provides database (QAR, SalesForce, etc.) support and generates reports to analyze and process data

* Travel to the various facilities including international subsidiaries

* Maintain reliable and consistent attendance, including being punctual, and dependable in order to meet the needs

of the department and the organization.

Execute each essential duty satisfactorily in order to perform job successfully.

* Follows all safety procedures required in work area, wears PPE as needed, attends all safety meetings, and reports

safety issues regarding equipment or unsafe/hazardous conditions.

* Performs effectively as a team member, able to work well with others, open to receive and give feedback, and

treats everyone with respect.

* Takes ownership of own work and behavior, accepts accountability for own actions, encourages solutions, and

communicates status of work/projects.

* Follow all department quality standards/criteria. Raise concerns and issues to immediate manager.

* Able to understand and demonstrate Cambro company culture, display company core values (Safety, Quality,

Respect, and Service).

* Understands department's key performance indicators and contributes to achieve these goals both individually

and as a team.

* Other duties as needed or required.

REQUIRED QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor's degree from a four-year college or university; or five or more years customer service-related experience and or manufacturing related experience and/or training; or equivalent combination of education and experience as applicable.

• Strong Computer skills required for reports, charts, data analysis and presentations.

• Excellent use of Excel, Word, Power Point, Outlook and Windows, Access experience a plus

• Excellent verbal and written communication skills with all levels and across the organization.

• Capable of managing priority changes.

• Must be self-motivated, highly driven, organized, result oriented and team player

PREFERRED QUALIFICATIONS

• Technical understanding and hands-on experience in the plastics industry, a position related to Engineering, Quality, or Manufacturing area is highly desirable.

PHYSICAL DEMANDS

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.

Sitting, walking, standing, bending at the neck, bending at the waist, squatting, twisting at the neck and waist, simple grasping, power grasping, fine manipulation, pushing and pulling, reaching above and below the shoulder, carrying/lifting up to 25 lbs.

• Working around equipment and machinery

• Exposure to excessive noise

PPE Requirements

• Safety glasses -while on production floor

• Hearing protection (e.g. ear plugs, ear muffs)as required in production areas

• Face covering (mask) in accordance with company policy.

COMPENSATION RANGE:

26.72 - $35.00

Salary may vary based on experience.

CAMBRO is proud to be an equal-opportunity workplace. All qualified applicants will receive consideration for employment without regard to and will not be discriminated against based upon race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic information, military or veteran status, or other characteristics protected by law. Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.