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Quality Assurance Manager

I am currently recruiting for the following openings:
Quality Assurance Manager, Harrisburg (Charlotte area), North Carolina (Permanent)
Our client is relocating to Harrisburg, NC. The company is expanding and possesses a great reputation within the medical devices industry. The position is permanent (full-time).
Company is offering a very strong total compensation package with an exemplary benefits package, second to none in the industry!
The individual we seek for this position should meet the following requirements:
Must be able to pass criminal background and drug screening check.
Must possess a verifiable employment history of success, with minimal or no gaps in employments.
Summary:
Reporting to the CEO, the Quality Assurance Manager coordinates and directs quality assurance programs designed to ensure continuous production of products consistent with established standards by performing the following duties personally or through designates.
Essential Duties and Responsibilities include the following (other duties may be assigned):
o Reviews quality system and products specifications with management to determine present
standards and to establish proposed quality and reliability expectancy of finished product
o Maintains quality control objectives complementary to corporate policies and goals
o Serves as point of contact and Audit Lead during regulatory inspections
o Serves as designated Management Representative for Quality System and leads annual Quality
Management Review
o Manages the ISO 13485 certification process
o Oversees and coordinates development of CE Tech files for designated products
o Manages CE Mark submission and approval process
o Participates in creating and implementing inspection and acceptance criteria and procedures
o Participates in creating assembly and work instructions
o Oversees product sterilization validation and aging studies, where applicable
o Reviews complaint records and helps develop corrective actions as needed
o With management develops annual internal quality audit schedule and audits quality system in
accordance with ISO/FDA requirements
o Helps ensure product labeling compliance with applicable regulatory standards
o Coordinates objectives with production procedures in cooperation with other team members to
maximize product reliability and minimize costs
o Provides inspection activity for product throughout production cycle
o Editing and implementing quality system and operating procedures
o Ensures that annual Device Establishment Registration and Listings are filed with FDA
o Supports FDA 510(k) writing and submissions
o Manages designated quality and regulatory consultants
o Serves on quality management and product development teams within organization, as required
o Participates in implementing quality control training programs to personnel
o Has the responsibility and authority to manage, perform and verify work affecting quality system
o Other duties and responsibilities may be assigned
Education, Experience, Knowledge, Skills and Abilities:
o Undergraduate diploma and minimum two years related experience and/or training; or equivalent
combination of education and experience
o 4+ years in Quality Assurance role a plus
o Lead Auditor certified i.e. ASQ CQA or two years related audit experience
o In depth understanding and application of FDA CFR guidelines and ISO 13485 requirements
o Computer skills including WORD, EXCEL, & VISIO
o Ability to read and interpret documents such as safety rules, operating and maintenance
instructions, and procedure manuals
o Ability to write routine reports and correspondence
o Ability to speak effectively before groups of customers or employees of organization
o Strong work ethic and understanding of quality systems
o Able to work well independently
o A strong and dedicated understanding towards customer and corporate needs and basic
requisites.
o Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers,
common fractions, and decimals
o Ability to speak effectively before groups of customers or employees of organization
Supervisory Responsibilities:
Directly supervises employees. Carry's out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Work Environment:
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 Quality Assurance Manager may have to manage a number of projects at one time, and may be interrupted frequently to meet the needs and requests of co-workers, clients and contractors. The office environment may be busy, noisy and will need excellent organizational and time and stress management skills to complete the required tasks.
Physical Demands:
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, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Training Requirements:
The employee must be trained on all of the documents, procedures, software applications and topics listed in the Skills Matrix. Documentation of this training will be maintained with Human Resources. Additional training requirements may be added as deemed necessary by the supervisor.
Compensation package will be discussed by Recruiter.
Please Note: If you are proactively looking for an opportunity, or would like to view our MANY openings, you may follow the link and instructions below to create your profile:
http://www.elitehealthcarejobs.com/registration/
To inquire, please submit your resume and salary requirements:
Mr. Sandy Watkins
Watkins Staffing, LLC.

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