Quality Assurance Manager

Katmai Government Services; Brilliant (OH); On-site; USD 54,000 - 66,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life & AD&D Insurance

Long-Term Disability Insurance

Short-Term Disability Insurance

401(k) Savings Plan

Vacation & Paid Personal Time

11 Paid Federal Holidays

Leave of Absence

Job summary

Katmai Government Services seeks a Quality Assurance professional to implement, monitor, and maintain the Quality System in accordance with FDA medical device and drug regulations.

Responsibilities include drafting and training on procedures, maintaining the Quality Manual and QA SOPs, conducting internal and external audits, CAPA reporting, and coordinating with Operations to ensure ongoing compliance across the plant.

Qualifications

• Minimum of three to five years in the medical device/drug industry, with a minimum of two years in QC/QA or equivalent
• Proven understanding of FDA regulations
• Proven leadership experience
• Must have clean driving record
• Must pass drug test
• Must obtain and maintain any necessary security access and/or background checks

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
• May provide technical guidance and/or supervision to personnel.

Skills

Quality Assurance

FDA Regulations

Leadership

Documentation

Quality System

Education

Bachelor's Degree preferred

Tools

Microsoft Excel

Microsoft Word

PowerPoint

Job description

Summary

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

• 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

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.

Requirements

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.

Benefits

Compensation & Benefits:

• Pay: $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), Vacation & Paid Personal Time, 11 Paid Federal Holidays, and Leave of Absence

Compliance:

To be considered for this position, all applicants must apply on the company website, https://apply.workable.com/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.

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).