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SUMMARY

Responsible for the implementation, monitoring and maintenance of the Quality System in accordance with FDA Medical Device and Drug regulations.

ESSENTIAL DUTIES & RESPONSIBILITIES

+ Ensure 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 Quality System Manual Standard Operating Procedures (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.

+ Perform other duties as assigned.

SUPERVISORY RESPONSIBILITIES

May provide technical guidance and/or supervision to personnel.

MINIMUM QUALIFICATIONS

+ Minimum of three (3) to five (5) years in the medical device/drug industry, with a minimum of two (2) years of direct experience in QC/QA or equivalent.

+ Proven understanding of FDA regulations.

+ Proven leadership experience.

+ Must have clean driving record.

+ Must be able to pass drug test.

+ Must obtain and maintain any necessary security access and/or background checks.

DESIRED QUALIFICATIONS & SKILLS

+ Bachelor's Degree preferred.

+ Strong Quality Systems background and knowledge of QA/QC principles and compliance.

+ Superior communication (verbal, written and interpersonal) skills.

+ Good organizational skills.

+ Motivated self-starter, ability to multi-task, work independently.

+ Aptitude for problem solving, decision making, and an effective cross-functional team participant.

+ Computer proficient, Microsoft Excel, Microsoft Word, and PowerPoint.

+ Confident team player with strong interpersonal skills.

+ Ability to work collaboratively across functions.

+ Possess and exhibit professionalism, energy, high integrity, results orientation, and solutions driven

WORK SCHEDULE

Full-time, Monday–Friday day shift. No weekends. May be required to work additional hours as needed to complete assignment or project.

TRAVEL

The expected travel time is less than 25%.

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, with or without accommodation, may be required when traveling for training and/or short occasional amounts of local driving. The expected driving time is less than 10%.

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.

PHYSICAL DEMANDS

Frequent sitting, using hands/fingers, handling, reaching with hands and arms, talking, hearing; occasional walking or standing, occasional lifting of up to 10 lbs. It is Katmai’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.

COMPENSATION & BENEFITS PACKAGE

+ Pay range: $60,000 per year.

+ Eligible Benefits: Medical, Dental, Vision, Life & AD&D Insurance, Long-Term & Short-Term Disability Insurance, 401(k) Savings Plan, Employee Assistance Program (EAP), Paid Time Off (PTO), 11 Paid Federal Holidays, and Leave of Absence.

_Compliance:_

_To be considered for this position, all applicants must apply on the company website,_ _https://katmaicorp.com/life-at-katmai/_

_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, marital status, familial status or any other characteristic protected by law._ _https://katmaicorp.com/life-at-katmai/#equal\_opportunity_ _Preference will be given to Ouzinkie Shareholders, Descendants of Shareholders and Spouses of Shareholders in accordance with Title 43 U.S. Code 1626(g) and Title 42 U.S. Code 2000e - 2(i)._

**Requisition ID:** 3885