QUALITY ENGINEER SUPERVISOR at KLS Martin L.P. in Jacksonville, Florida

Job Description:

Job Details

Job Location: Corporate Office - Jacksonville, FL

Position Type: Full Time

Salary Range: Undisclosed

Job Summary

Manages production processes at KLS, with focus at KLS MM manufacturing validation processes. Supervise Quality Engineer Team is in compliance with 13485, 21CFR 820 and SOR 98/282. Exercises discretion and independent judgement related, but not limited to, adverse event and the quality management system.

Essential Functions, Duties, and Responsibilities

• Prioritize, directs and implements process validations.
• Works with RA/QMS Management & KLS MM Production to ensure processes are in compliance.
• Authors, reviews & approves IQ/OQ/PQ validation protocols and reports.
• Authors, reviews & approves equipment qualifications.
• Creates and revises Standard Operating Procedures (SOPs) and Work Instructions (WIs) as required with respect to equipment and validation of processes.
• Leads work with cross functional teams to assist in production process compliance
• Provides input into quality data with KLS MM processes to equipment and validations
• Oversight of calibration program at KLS MM in collaboration with the QMS Team
• Performs other related duties as assigned

The above cited duties and responsibilities describe the general nature and level of work performed by people assigned to job. They are not intended to be an exhaustive list of all the duties and responsibilities that an incumbent may be expected or asked to perform.

Educational and Experience Requirements
4 year degree with preferred 8 years work experience in a regulated industry or
8 years of experience in regulated industry specific to job role
Experience and intermediate knowledge of MS Excel
Knowledge and experience with application of 21CFR820 and 13485:2016
Minitab experience preferred

Knowledge, Skills, and Abilities
Maintains high integrity and confidentiality of company and department information
Ability to work effectively with all levels of internal and external associates, customers, and colleagues
Excellent interpersonal skills with the ability to effectively communicate at all levels internally as well as externally
Ability to follow through on issues, make informed decisions that comply with policies and procedures, complete tasks and problem solve
Ability to work with minimal supervision
Ability to manage multiple priorities

Skill Requirements
Typing/computer keyboard
Utilize computer software (specified above)
Retrieve and compile information
Verify data and information
Organize and prioritize information/tasks
Advanced mathematical concepts (fractions, decimals, ratios, percentages, graphs)
Verbal communication
Written communication

Physical Requirements
Sitting for extended periods
Extended periods viewing computer screen
Walking
Reading
Speaking
Hear/Listen
Maintain regular, punctual attendance
Writing

Hazards
Normal office environment

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Job Summary

Manages production processes at KLS, with focus at KLS MM manufacturing validation processes. Supervise Quality Engineer Team is in compliance with 13485, 21CFR 820 and SOR 98/282. Exercises discretion and independent judgement related, but not limited to, adverse event and the quality management system.

Essential Functions, Duties, and Responsibilities

• Prioritize, directs and implements process validations.
• Works with RA/QMS Management & KLS MM Production to ensure processes are in compliance.
• Authors, reviews & approves IQ/OQ/PQ validation protocols and reports.
• Authors, reviews & approves equipment qualifications.
• Creates and revises Standard Operating Procedures (SOPs) and Work Instructions (WIs) as required with respect to equipment and validation of processes.
• Leads work with cross functional teams to assist in production process compliance
• Provides input into quality data with KLS MM processes to equipment and validations
• Oversight of calibration program at KLS MM in collaboration with the QMS Team
• Performs other related duties as assigned

The above cited duties and responsibilities describe the general nature and level of work performed by people assigned to job. They are not intended to be an exhaustive list of all the duties and responsibilities that an incumbent may be expected or asked to perform.Educational and Experience Requirements
4 year degree with preferred 8 years work experience in a regulated industry or
8 years of experience in regulated industry specific to job role
Experience and intermediate knowledge of MS Excel
Knowledge and experience with application of 21CFR820 and 13485:2016
Minitab experience preferred

Knowledge, Skills, and Abilities
Maintains high integrity and confidentiality of company and department information
Ability to work effectively with all levels of internal and external associates, customers, and colleagues
Excellent interpersonal skills with the ability to effectively communicate at all levels internally as well as externally
Ability to follow through on issues, make informed decisions that comply with policies and procedures, complete tasks and problem solve
Ability to work with minimal supervision
Ability to manage multiple priorities

Skill Requirements
Typing/computer keyboard
Utilize computer software (specified above)
Retrieve and compile information
Verify data and information
Organize and prioritize information/tasks
Advanced mathematical concepts (fractions, decimals, ratios, percentages, graphs)
Verbal communication
Written communication

Physical Requirements
Sitting for extended periods
Extended periods viewing computer screen
Walking
Reading
Speaking
Hear/Listen
Maintain regular, punctual attendance
Writing

Hazards
Normal office environment

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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