Quality Assurance Specialist I
Sorry, this particular job is closed. But feel free to fill out a General ApplicationSearch Jobs
Quality Assurance Specialist I
Title:Quality Assurance Specialist I
Quality Assurance Specialist I
Location: Memphis, TN
Shift: 1st shift, Monday - Friday
Under some supervision and with a good understanding of science and technology, monitors operations and participates in quality improvement initiatives to ensure that systems are safe, effective, appropriate, compliant, current, and adhered to by staff for the company’s North American operations.
- Support the organization in monitoring of the compliance of laboratory testing, manufacturing, and clinical research and ensuring continued effectiveness of the QMS according to CLIA, CAP, HIPAA, GCP, GLP, GDP, and QSR requirements.
- Prepare, maintain, analyze, and present metrics related to the quality systems.
- Conduct and/or support internal audits, client audits, supplier audits, and regulatory audits including, but not limited to: audit scheduling, audit preparation, audit execution, audit response/resolution, and audit follow-up.
- Work to accomplish efficient and effective quality review/audit of: certificates, procedures, protocols, risk assessments, reports, IQ/OQ/PQ documents, validations, deviations, complaints, and non-conformances/CAPAs, or other quality records, and provide professional and objective feedback based on the results.
- Communicate effectively with internal personnel, as well as external customers and suppliers.
- Collaborate effectively and positively within department and all other company departments.
- Represent department and the organization favorably and in accordance with established Company standards.
- Follow all company safety policies & other safety precautions within work area
- Regular attendance and timeliness is essential
- Additional daily duties as required:
- Non-conformance and CAPA: Participate in the tracking, trouble shooting, investigation and progression of corrective and preventive actions related to non-conforming product or deviations from approved processes.
- Complaints: Participate in the logging and investigation of customer complaints and feedback to the sales team.
- Change Control: Review, provide quality insight and support change control process for procedures, methods, equipment, and computer systems.
- Document Control: Facilitate process for new, revised, and obsoleted documents (policies, procedures, forms, templates, marketing materials, etc.) and ensure proper tracking for status.
- Training: Conduct and/or support continuous quality training including, but not limited to: induction/orientation, ongoing quality training, and annual regulatory training requirements.
- Incoming Quality Control: Assist in conducting inspections of raw materials for manufacturing and laboratory testing reagents and consumables.
- Equipment: Ensure that equipment maintenance and servicing is performed according to specifications and that all equipment is qualified for use appropriately.
- Process Validation: Support validation of laboratory procedures, collect and analyze data, and perform routine document review and special audits.
- Reporting: Organize reports and interdepartmental meetings as required.
- Other duties as assigned by management
- Bachelor’s degree in a life science
- 1-5 years Quality experience, preferably in laboratory setting
- Medical device experience a plus
- Good working knowledge of MS programs
- Experienced in working to CAP/CLIA/GCP/GLP and Quality Management principles
- Strong attention to detail and Quality commitment
- High standards of mathematics and writing ability
- Conscientious, thrives in high pressure work, and demonstrates strong initiative
The physical demands described within the Position Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Minimal travel required including international travel. Job requires employee to walk considerable distances in the facility during the course of his or her work.
- Kitter-Assembler in Norwood MA
- Design Assurance Quality Engineer in Brooklyn Park MN
- Buyer in Woburn MA
- Facility Technician in Alpharetta GA
- Design Engineer in Lawrenceville GA
- Test Tech in Westborough MA
- Punch Press Operator in Alpharetta GA
- Sr R&D Technician in Eden Prairie MN
- Purchasing Contractor in East Boston MA
- NDT Level III Inspector in Central Manchester CT
- Technician-Machine operator in N. Billerica MA
- Test Specialist in Suwanee GA
- HR Manager in Clinton MA
- Material Handler 2nd shift in Westborough MA
- Accounts Payable Temp in Buford GA
- Manual Machinist in Peabody MA
- Mechanical Design Engineer in Beverly MA
- Facilities EHS Manager in Southbridge MA
- EM assembler in Leominster MA
- Bench Repair Technician in Kennesaw GA
- Quality Engineer in Newnan GA
- Buyer in Duluth GA
- Manufacturing Engineer in Atlanta GA
- Customer Service Representative in Oakdale MN
- EM Assembler in Waltham MA
- Financial Analyst in Westford MA
- Material Handler in Waltham MA
- CNC Machinist in Murrayville GA
- Press Brake Operator in Alpharetta GA
- Customer Service Representative in Norfolk MA
- Principal-Secondary Assembly in Wilsonville OR
- Control Panel Point to Point Wirer in Wilsonville OR
- Machine Operators in Lebanon NH
- Electrician in Cumming GA
- Solder Assembler in Natick MA
- Solidworks Drafter in Portsmouth NH
- Mechanical Technician - Assembler in Eden Prairie MN
- Wire Machine Operator in Ayer MA
- Sr. Corporate Accountant in Billerica MA
- 3rd Shift Assembler in Suwanee GA
- 2nd Shift Assembler in Suwanee GA
- 1st Shift Assembler in Suwanee GA
- Accounts Payable Supervisor in Milford MA
- Lean Manager in Milford NH
- Packaging Technician in Sutton MA
- Logistics System Coordinator in Everett MA
- Sr. Engineer in MA
- Industrial Painter in Duluth GA
- Administrative Assistant in Bartlett TN
- Project Manager CAD Tech in Bartlett TN
- Refrigeration Tech in Acton MA
- Control Panel Wirer Technician in Acton MA
- Test Technician in Acton MA
- Sales Administrator in Needham Heights MA
- Solidworks Drafter in Kennnesaw GA
- Welder in Flowery Branch GA
- Program Manager II in MA
- Warehouse in Suwanee GA
- ID-OD GRIND MACHINIST in Santa Fe Springs CA
- Assembly Technician in Worcester MA
- Mechanical Assembler (1st Shift) in Ashland MA
- Test Technician in Worcester MA
- Quality Control Inspector in Worcester MA
- Test Tech I PCB in Westboro MA
- QA Mechanical Inspector in Ashland MA
- Mechanical Assembler in Westborough MA
- Mechanical Inspector II - RII in Westborough MA
- Solder Assembler II in Westboro
- Material Handler in Suwanee GA
- Mechanical Assembler in Duluth GA
- EHS Coordinator - Environmental Health and Safety in Maple Grove MN
- Mechanical Assembler in Buford GA
- Administrative Assistant in Sudbury MA
- 2nd Shift Machinist in Newton MA
- Sr. Sales Rep in woburn MA
- CNC Operator in Ashland MA
- Documentation Specialist in Ayer MA
- Mechanical Assembler in Waltham MA
- Production Manager in Lynn MA
- Material Coordinator in Worcester MA
- Director Of Operations in Memphis TN
- Executive Assistant in Milford MA
- EM Assembler in Malborough MA
- Material Handler in Memphis TN
- Entry Level Machine Operator - Die Cut collector in Sutton MA
- Machine Operator in Sutton MA
- Systems Engineer in Watertown MA
- Productions Ops Tech II in
- Accountant in Bartlett TN
- Manufacturing Engineer in Portsmouth NH
- Accounting Analyst in King of Prussia PA
- Senior Electrical Engineer in Waltham MA
- Principal Electrical Engineer in Waltham MA
- Sales Administrative Assistant in Lawrenceville GA
- Expeditor-Data Entry Admin in Lawrenceville GA
- Material Handler II in Westboro MA
- Quality Documentation Coordinator in Bloomington MN
- Sr Quality System Engineer in Eden Prairie MN
- Assembly Technician in Hollis NH
- Quality Engineer in Peterborough NH