Quality Specialist Position Available In Jefferson, Alabama

Quality Specialist Rampart IC Birmingham, AL Job Details Full-time $65,000 – $75,000 a year 16 hours ago Benefits Health insurance Dental insurance Paid time off Vision insurance 401(k) matching Life insurance Qualifications Mid-level Microsoft Office 3 years Analysis skills Bachelor’s degree Certified Quality Auditor Organizational skills Computer skills Manufacturing Associate’s degree Communication skills

ISO 13485

Certified Quality Engineer FDA regulations Full Job Description Job Overview Rampart is seeking a dedicated and detail-oriented Quality Specialist to join our growing team. This position offers a collaborative working environment where you will contribute and assist with maintaining and enhancing quality standards, equipment and process validation, execute internal audits working closely with engineering and manufacturing functions, and ensuring our products meet the highest quality requirements and specifications. This position reports directly to the Director of Quality Assurance/Regulatory Affairs.

JOB RESPONSIBILITIES AND DUTIES

Consistently models the core values of the company both internal and external the company. Openly commits to and supports company processes and systems. Ensure QMS compliance in all duties to applicable regulatory requirements; including, but not limited to the following: 21 CFR Part 820, ISO 13485, and

ISO 14971

Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Develops work instructions and procedures for manufacturing processes Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Coordinates calibration equipment and activities Performs process validations as required Conducts quality assurance tests; and determine the responsibility for products or materials that do not meet required standards and specifications. Collaborate with cross-functional teams to address any quality-related issues and implement Corrective Actions- Drives corrective action activities. Performs root cause analysis, monitoring of open NCR/CAPA’s/SCAR’s. Ensures that corrective measures meet acceptable standards, and that documentation is compliant with requirements. Specialize in the areas of, incoming material, production control, product evaluation, and/or research and development as they apply to product or process quality. Gatekeeper for all incoming parts / components. Ensuring Production Feedback Reports, NCRs, and CAPAs are created for product and process issues found in Production. Investigate customer complaints and document results. Document /Change control – Monitoring of open change control, raising new change control as needed Provides training for quality and manufacturing personnel as applicable. Assists with Risk Management activities. Assists with Supplier quality assurance development. Ensuring suppliers are meeting the quality standards as specified in supplier quality agreements. Assists with internal auditing activities Ensure that the Device History Record (DHR) is up to date for the products manufactured Any other duty as required by supervisor. Key Metrics CAPA’s Acceptance Activities NCR’s

QUALIFICATIONS / EDUCATION AND EXPERIENCE

Bachelor’s or associate degree with 3 years of quality experience from a regulated industry. Working knowledge of

ISO 13485, ISO

14971 and

FDA 21 CFR

Part 820 & GDP Demonstrated ability to work collaboratively in cross-functional teams Proficiency with the Microsoft Office suite and Google Drive platform. Excellent interpersonal and communication skills. Strong analytical, decision-making, and problem-solving skills.

ADDITIONAL DESIRABLE QUALIFICATIONS SKILLS AND KNOWLEDGE

Background in Medical Device manufacturing, preferred, previous quality experience in manufacturing environment, Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) or lead auditor are desirable but optional. Strong Written and Verbal Communication Organizational Skills Ability to work under pressure, plan personal workload effectively to prioritize responsibilities

PHYSICAL ACTIVITIES

The physical demands described here are representative of those that must be met by the employee to successfully perform the essential functions of this position.

Body Positions:

Regularly required sitting, standing, and walking for pro-longed periods of time.

Body Movements:

Full range of body movements including the use of hands and fingers, to handle or feel objects, including computer equipment and peripherals, and bending, reaching, lifting, and crouching.

Vision:

Ability to read and see Instructions, computer screens, and small parts for assembly.

MENTAL REQUIREMENTS

Analytical:

Must be able to synthesize complex or diverse information. Must possess logical and deductive reasoning skills.

Problem Solving:

Must be able to identify and resolve problems in a timely manner and gather, prepare and analyze complex information and reports.

Relational:

Must be able to comfortably connect and work with different personalities both inside and outside the company.

Communication Skills:

Must be able to read and write well to communicate effectively with all persons concerned or related to the business.

WORKING CONDITIONS

Work may include extended periods of time viewing a computer monitor and/or operating a keyboard. Work may include extending periods of time standing, moving, crouching, bending, and lifting.

Tips:

Provide a summary of the role, what success in the position looks like, and how this role fits into the organization overall.

Job Type:

Full-time Pay:

$65,000.00 – $75,000.00 per year

Benefits:

401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance

Schedule:

8 hour shift

Location:

Birmingham, AL 35211 (Preferred) Ability to

Commute:

Birmingham, AL 35211 (Required)

Work Location:

In person