Quality Assurance Specialist
Company: Lima Corporate
Posted on: August 7, 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 operationsEducation &
- 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
preferentialWhat 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 ProgramsAbout 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 including fixation.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 opportunity employer.
Keywords: Lima Corporate, Arlington , Quality Assurance Specialist, Other , Arlington, Texas
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