Quality Assurance/Medical Device
kyyba
Scarborough, ME
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JOB DETAILS
SALARY
$28–$31 Per Hour
JOB TYPE
Temporary, Contractor, Full-time
SKILLS
Biology, Calibration, Change Control, Change Management, Chemistry, Control Systems, Corrective and Preventative Action (CAPA) Systems, Detail Oriented, Document Archiving, Document Control, Healthcare Quality, Infectious Diseases, Internal Audit, Inventory Management Software, Manufacturing, Manufacturing/Industrial Processes, Mathematics, Microsoft Excel, Microsoft Word, Operational Audit, Organizational Development/Management, Proofreading, Quality Assurance, Quality Control, Quality Management, Record Keeping, Records Management, Reporting Skills, Retention Programs, Standard Operating Procedures (SOP), Systems Maintenance, Test Plan/Schedule, Testing, Writing Skills
LOCATION
Scarborough, ME
POSTED
7 days ago
Quality Assurance Specialist/MED Device/MFG
44820 29-31.00 an hour w2 contract through EOY
The position of Quality Assurance Specialist II is within our Infectious Disease Business
Unit located at Scarborough, Maine. In this role you will, under minimal direction, perform a wide variety of activities to support the Quality Management System.
This job description will be reviewed periodically and is subject to change by management.
RESPONSIBILITIES:
The following activities may be assigned as applicable:
Quality System Management
§ Review production batch records (DHRs) for accuracy and completeness in order to
approve intermediate products for use in production. Review finished goods batch
records. Report deviations in these records and assure they have been addressed and
resolved prior to issuing approval.
§ Conduct spot-check inspections/audits of production operations
§ Participate in the internal audit program
§ Write, review and approve Standard Operating Procedures (SOPs) as necessary
§ Assist with and may write validations/test protocols as necessary
§ Assist in testing of complaint samples and stability samples and report results out of
acceptance limits
§ Provide backup to other Quality Specialists
§ Initiate and author Deviations and Quality Incidents (QI)
§ May administer the calibration program
§ May administer the document control system
§ May administer the Deviation, Quality Incident and CAPA programs
§ May organize the long-term stability program and be responsible for administering the
sample retention program
§ May administer the Quality Records program and assist and act as backup to the
Document Control Specialist II
§ Train new and current Quality Assurance Technicians and Specialists as needed
§ Other duties may be assigned.
Change Control Management
· Change Management Documentation
Assignment of Design History File numbers
Compile and maintain quality system records associated with design change
projects, including project definitions, first-lot-to-stock, product qualification
records, etc.
Ensure records for design change projects are complete and align with SOPs
Manage organization, storage, and archival of documentation and records
associated with design changes and labeling
· Labeling Process Administration:
Provide proofreading of product labeling prior to team review and approval
Initiate, execute and implement label changes in coordination with
interdepartmental and external stakeholders
· Change Control Execution:
Assist with implementation of product changes, in conjunction with project leads
Manage assigned Design Change projects (typically associated with product
labeling)
§ Other duties may be assigned.
BASIC QUALIFICATIONS | EDUCATION:
· Bachelor's Degree in Chemistry, Biology, Life Science, or other related technical field in a
scientific or technical area or the equivalent combination of education and experience
· Minimum three years in a Quality Assurance role for manufacturing.
PREFERRED QUALIFICATIONS:
3+ years prior experience in a Quality Assurance role or similar support role in the medical
device industry
COMPETENCIES:
· Ability to follow procedures and accurately document results
· Knowledge of site software for inventory management, document control and quality
incident tracking
· Good working knowledge of Excel and Microsoft Word software
· Ability to understand manufacturing processes of Company products and ability to
recognize deviations from approved documented procedures
· Ability to read and interpret documents such as safety rules, operating and maintenance
instructions, and procedure manuals
· Ability to write routine reports and correspondence
· Ability to speak effectively before groups of customers or employees of organization
· Ability to interpret a variety of instructions furnished in written, oral, diagram, or
schedule form
· Ability to apply mathematical concepts such as fractions, percentages, ratios, and
proportions to practical situations
· Attention to detail
About the Company
k
kyyba
Kyyba group of companies are privately held and specialize in staff augmentation, application software and project solutions. In operation for more than 15 years, we have earned an enviable track record and reputation within all the industries we serve. Our unique processes and maturity enables us to understand the needs of the business organizations and provide business solutions that match the real and compelling needs of our customers.
Headquartered in Michigan, Kyyba has multiple office locations and we serve local, regional and national client base consisting of Fortune 500 and middle market companies. Kyyba extends the above solutions and services to a broad spectrum of industry verticals ranging from automotive, insurance, technology, financial, transportation, government and so on.
COMPANY SIZE
100 to 499 employeesINDUSTRY
Staffing/Employment Agencies
FOUNDED
1998
WEBSITE
http://www.kyyba.com/