Quality Assurance Specialist
Company: Lima Corporate
Posted on: August 6, 2022
Lima USA is looking for a skilled and passionate Quality
Assurance Engineer to join our family.
The role, reporting to the Sr. Quality Assurance Specialist will
lead and support quality related activities within the business:
incoming, in-process and final inspection, product/processes
conformity audits, quality system audits and international standard
compliance. Identify and implement procedures to continuously
improve the quality system.
Specific Job Responsibilities:
- Support the management of Lima USA Quality System.
- Ensure that the facility's Quality System is established and
maintained in compliance with applicable local ordinances, State
statues, and Federal regulations, and other laws, including Title
21 CFR 820 Regulations.
- Maintain compliance with FDA 21 CFR Part 820 Quality System
- Manage the measuring equipment (selection, identification,
calibration and maintenance).
- Support internal and supplier related quality issues.
- Understand and communicate regulations and guidelines and
assess the implications for strategic business decisions.
- Implement, maintain, and enhance programs and procedures which
guarantee the continuous improvement of organizational
- Plan Internal Audits, monitoring their performance and the
management of any non-conformity.
- Interface with compliance / regulatory agencies (e.g.
- Interface with all applicable vendors, suppliers, customers,
and contractors, and consultants.
- Manage complaints, Non-conformities and CAPAs.
- Carry out periodic reviews of the Quality System, collecting
and analysing data related to processes performance.
- Ensure correct and efficient execution of the receiving
inspection, in-process inspection, and final release.
- Plan, develop, and document the quality systems procedures for
- Ensure that all necessary documentation for release of product
is completed and all specifications have been met prior to release
of any component.
- Manage the sites training program to verify that plant
personnel are trained on GMP/QSR requirements.
- Make recommendations for process improvements and participates
in planning and implementing changes to quality and operations
process control requirements and the sites associated
- Review new documents, as well as changes to existing documents,
to assure enhanced quality and productivity, while maintaining
compliance with FDA requirements.
- Perform trend analysis of data associated with quality problems
to detect negative trends and to recommend corrective/preventive
actions for problem resolution.
- Other duties as assigned by the General Manager.
Technical & Soft Skills required:
- Knowledge of organizational processes
- Competence in laboratory and production testing
- Knowledge of data analysis techniques
- Knowledge of audit management techniques
- Proficiency in English (written and spoken)
- Strong communication & interpersonal skills
- Result-driven orientation
- Ability to team-working
- Ability to raise awareness on quality issues
- Internal and external client-orientation
- Problem solving ability
- Detailed knowledge of US GMP/QSR (21CFR820), ISO 9001/13485,
and related quality standards
- Excellent verbal and written communication skills
- Ability to train technical, professional, and managerial level
- Strong knowledge of FDA regulatory requirements and of standard
quality assurance practices for manufacturing operations
Education & Experience:
- Bachelor's degree in Engineering, Operations or related field
- Minimum of three (3) years prior experience in Quality Systems
at a Quality Assurance or Quality Engineering level
- Experience with Class II or Class III medical devices is a
What We'll Provide:
- More than just, our Total Rewards package connects team members
to what matters most. Team members are eligible to begin receiving
benefits on their first day of employment. Below are just some of
current benefit offerings:
- Comprehensive Medical, Dental, and Vision Insurance Plans
- Company Paid Life Insurance
- Company Paid Short-Term and Long-Term Disability
- 401(k) with company matching
- Paid Time Off (including Vacation, Paid Sick Time, and Company
- Maternity/Paternity Leave
- Professional Development Programs
About Lima USA:Lima USA is a proud subsidiary of LimaCorporate, a
global orthopedic medical device company providing reconstructive
and fixation orthopedic solutions to surgeons who face the
challenges of improving their patient's quality of life.
We are committed to the development of innovative products and
procedures to enable surgeons to select ideal solutions for every
individual patient. Our product range includes large joint
primary/revision implants and complete extremities solutions
We aspire to be the leading company in niche orthopedic markets to
improve surgeon and patient experience, offering innovative,
tailored solutions with established direct subsidiaries in 23
countries across the globe, covering and supporting over 42
countries worldwide! We offer innovative solutions to assist
orthopedic surgeons in restoring the eMotion of Motion.
At Lima USA, we want all of our team members to experience Lima USA
as "a place where I belong." Our goal is to embed diversity and
inclusion into everything we do, so it becomes part of who we are.
As such individuals are recruited, hired, assigned, and promoted
without regard to race, national origin, religion, age, color, sex,
sexual orientation, gender identity, disability, protected veteran
status, or any other protected characteristic. Lima USA is an equal
Keywords: Lima Corporate, Arlington , Quality Assurance Specialist, Other , Arlington, Texas
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