Location: Brilliant,OH, USA
Position is responsible for the implementation, monitoring and maintenance of the Quality System in accordance with FDA Medical Device and Drug regulations. Responsibilities will also include ensuring the Quality System regulations are understood by all applicable company personnel and is functioning and effective at all times.
* Draft, review, maintain, distribute and train personnel on facility documentation and procedures, such as the Quality Manual and Quality System Procedures.
* Ensure compliance with Document Control, Device History Records and Management.
* Maintain QSM SOPs, and Documentation Control.
* Prepare documentation and systems for compliance with the FDA requirements.
* Conduct and participate directly in quality inspections, internal and external audits, and FDA inspections.
* Participate in CAPA systems. Prepare reports and corrective actions.
* Maintain and update the Quality Manual, QA Procedures, and introduce Quality Plan improvements as applicable.
* Assist in analyzing and evaluating information concerning manufacturing problems, customer complaints, non-conformances, quality system, etc.
* Trend customer complaints and/or non-conformances.
* Assist and/or perform training activities in QM system processes and product quality.
* Confer with Operations about quality assurance and regulatory issues of products to ensure compliance with quality system.
* Maintain regular and punctual attendance.
* Other duties as assigned.
Supervisory Responsibilities:
May provide technical guidance and/or supervision to personnel.
Physical Demands:
Frequent sitting, using hands/fingers, handling, reaching with hands and arms, talking, hearing and seeing up close, at a distance, along the periphery, with depth perception and the ability to adjust focus); occasional walking or standing, occasional lifting of up to 10 lbs. It is Katmai Government Services, LLC's business philosophy and practice to provide reasonable accommodations, according to applicable state and federal laws, to all qualified individuals with physical or mental disabilities.
Work Environment:
The majority of work is performed in a professional office setting and in some off-site locations during project transitioning with a wide variety of people in different functions, personalities and abilities.
Work Schedule:
Full-time. May be required to work additional hours as needed to complete assignment or project. May require flexible work schedule. Extensive travel required
Job Requirements
Minimum Qualifications:
* Bachelor's Degree preferred
* Minimum three to five years in the medical device/drug industry, with a minimum of 2 years direct experience in QC/QA or equivalent.
* Strong Quality Systems background and knowledge of QA/QC principles and compliance.
* Proven understanding of FDA regulations.
* Proven leadership experience.
* Superior communication (verbal, written and interpersonal) skills.
* Good organizational skills.
* Motivated self-starter, ability to multi-task, work independently and also collaboratively.
* Aptitude for problem solving, decision making, and an effective cross-functional team participant.
* Computer proficient, Microsoft Excel, Microsoft Word, and Power point.
* Individual must be a confident team player with strong interpersonal skills, an active communicator who can work collaboratively across functions. Individual must possess and exhibit professionalism, energy, high integrity, results orientation and solutions driven.
Driving Requirement:
Must have or be able to attain a valid state driver's license and be insurable on the company's automobile insurance policy.
Driving may be required when traveling for training and/or short occasional amounts of local driving. The expected driving time is less than 10%.
Travel:
May be required to travel.
Compliance:
To be considered for this position, all applicants must apply on the company website,
We are a VEVRAA Federal Contractor
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity or national origin, disability status, protected veteran status, or any other characteristic protected by law.
Preference will be given to Ouzinkie Shareholders, Spouses of Shareholders, and Descendants of Shareholders in accordance with Title 43 U.S. Code 1626(g) and Title 42 U.S. Code 2000e - 2(i).
Executive Order 11246, as amended, protects applicants and employees from discrimination based on inquiring about, disclosing, or discussing their compensation or the compensation of other applicants or employees.
Benefits Package
Eligible
Education
Bachelor's Degree
Category
Professional
Exemption Type
Exempt
Travel
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