Manager, Quality Operations
Company: Careerbuilder US
Location: Knoxville
Posted on: January 12, 2021
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Job Description:
PURPOSE AND SCOPE: Manages and oversees Quality Operations at
the facility. Ensures in-process quality controls conform to
company requirements and to all applicable state, federal, and
international regulations. Ensures that calibration of equipment
and instruments conform to their use. Ensures quality of
software/process validations and their respective integration with
calibration. Ensures Risk Management program at facility conforms
to company requirements and all applicable regulations. Ensures the
product release meets requirements and specifications. PRINCIPAL
DUTIES AND RESPONSIBILITIES: Manages the tactical execution of
short- and long-term objectives through the coordination of
activities with a direct responsibility for results, including
costs, methods, and staffing. Provides leadership, coaching, and
development plans for all direct reports to maintain an engaged and
productive workforce; partnering with Human Resources on employee
matters. Manages the budget for Quality Operations and stays within
the approved budget target. Responsible for preparing and managing
the budget for the Quality Department. Oversees the Risk Management
Program and serves as Risk Management Manager for the facility.
Serves as Validation Committee Chairperson. Acts as independent
reviewer for design control activities, as assigned. Responsible
for assigning designates for these responsibilities. Ensures risk
management activities, process qualifications, and validations are
appropriately performed and documented. Maintains knowledge of pre
and post production quality planning, monitoring /trending, and
internal audits. Ensures risk evaluations and risk reviews are
performed in a timely manner and the risk management documents are
updated accordingly. Ensures process changes are evaluated for
impact on product and associated risk controls. Ensures the
development and maintenance of data collection and analysis
systems. Ensures the development, rationale, and review of process
and product specifications, and sampling plans. Creates quality
records in the form of reports and oversees the creation of
inspection records, specifications and other reports and
communications. Ensures monthly trending is conducted on each
product line and reported in the periodic meetings and monthly
reports. Develops, implements, and continuously improves the system
for calibration at the facility. Supports other facilities within
FMCNA. Ensures systems conform to company requirements and all
applicable state, federal, and international regulations. Develops,
implements, and continuously improves the system for
process/software validation, and design transfer. Ensures these
systems conform to company requirements and to all applicable
state, federal, and international regulations. Develops and
maintains a system to integrate calibration, validations, tolerance
stacking, risk evaluation, laboratory testing, etc. in order to
develop appropriate validation and design transfer requirements.
Serves as review committee member for calibration systems,
process/software validation systems, and design transfer. Reviews
process/software validation plans, SRS, SPR, test cases, IQ/OQ/PQ
activities, etc. Develops and maintains process for first article
inspections at Knoxville facility. Provides technical support for
other facilities. Ensures QS software conforms to the software
validation system. Ensures the QS data sources are maintained and
administered appropriately to provide the quality records. Composes
and presents monthly summary reports to management summarizing
activities, including trending and graphic representations.
Provides guidance to plant personnel/management in developing
calibration requirements, validation packages, risk management,
etc. Follows processes and operational policies in selecting
methods and techniques for obtaining solutions. Interprets and
recommends change to policies and establishes procedures that
effect immediate organization(s). Frequently interacts with
subordinate supervisors, customers, and/or functional peer group
managers, normally involving matters between functional areas,
other company divisions or units, or customers. Responsible for
hiring, coaching, and counseling employees, including performance
reviews, disciplinary action, and terminations. Adheres to Company
Values: Honesty & Integrity, Quality, Respect & Dignity, Innovation
& Improvement, Teamwork & Safety are the guiding principles of
employee behavior at FMCNA. Provides technical guidance. Observe
and practice all safety policies and evacuation procedures.
Maintains general housekeeping of working area and plant. Strives
to continuously build knowledge and skills. Assists with various
projects as assigned. Other duties as assigned. Additional
responsibilities may include focus on one or more departments or
locations. See applicable addendum for department or location
specific functions. Job Requirements: PHYSICAL DEMANDS AND WORKING
CONDITIONS: The physical demands and 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.
Frequently required to stand, sit, and walk. Occasionally required
to use hands and fingers to handle, feel, reach with hands and
arms; talk or hear and wear personal protective equipment that may
include safety glasses, hearing protection, hair net, smock, etc.
The employee must regularly lift and/or move up to 10 pounds,
frequently lift and/or move up to 35 pounds. Occasionally exposed
to moving mechanical parts. The noise level in the work environment
is usually moderate. Donning/Doffing is required. SUPERVISION:
Responsible for the direct supervision of various levels of Quality
Operations staff. EDUCATION: Bachelor---s Degree required in
engineering, science, mathematics, statistics, or other technical
field; Advanced Degree desirable Member of ISPE, PDA, AMMI, ASQC or
other trade association helpful. ASQ certified Quality Engineer and
Manager of Quality/Organizational Excellence preferred. EXPERIENCE
AND REQUIRED SKILLS: Minimum 6 --- 8 years of related experience
required, preferably with medical device or drug-related
manufacturing. 3 years of supervisory or project/program management
experience preferred. Strong knowledge of FDA regulatory
requirements (cGMP/QSR) and of standard quality assurance practices
for medical manufacturing operations. Professional quality
discipline certifications (CQE, CQA, CQM or RAB) desired. Should be
familiar with techniques for ensuring data accuracy and integrity,
and be able to supervise root cause analysis methods and corrective
action investigations. Ability to read, analyze, and interpret
common scientific and technical journals, financial reports, and
legal documents. Ability to respond to common inquiries or
complaints from customers, regulatory agencies, or members of the
business community.
Keywords: Careerbuilder US, Knoxville , Manager, Quality Operations, Executive , Knoxville, Tennessee
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