11 Jobs in Newton, MA
APN Software Services, Inc is Hiring a Sr. Quality Assurance Engineer (W2 role) Near Newton, MA
- Interface with all departments in the organization in matters related to the quality system compliance.
- Propose, lead, initiate and follow-up on Corrective Action and Preventive Actions (CAPA).
- Support the Internal Audit program and provide backroom support for External Audits (Regulatory, Notified Body, and Customer).
- Assist in the management of a Calibration and Preventative Maintenance program.
- Disposition non-conforming material (NCMR).
- Support product complaint investigations leading to root cause determination.
- Support updates to the Risk Management File (FMEA, Hazard Analysis, Post Market Surveillance Reports, etc.).
- Review and as needed update QMS procedures (SOPs, Work Instructions, Forms) to reflect latest industry standards, guidance documents and best practices.
- Support the completion of validation protocols and test plans (IQ, OQ, PQ, test method and inspection method qualification).
- As appropriate, assist in supplier qualification activities (initial assessments and categorization).
- Other duties as assigned by manager.
- Minimum 4-year degree in Engineering/Bio-Medical Engineering or Life Sciences (in lieu of degree additional work experience will be considered.)
- 7 to 10 years of experience as a Quality Engineer in the medical device industry; QMSR/ MDD/MDR and ISO-13485 experience required.
- Notified Body/Regulatory Audit experience; Certified Quality Auditor (CQA) certificate is preferred.
- Must have experience in CAPA, NCMR, Internal/External Audits, calibration/preventive maintenance activities, risk management activities, and design controls.
- Technical skills including the ability to read technical specifications and interpret industry standards and regulations.
- Effective and professional communication skills; Internal (engineering, operations, R&D, etc.) and external (customers, auditors and suppliers) required.
- Effective time/task management skills; excel working in a fast-paced environment.
Additional Details
- Does this worker qualify for overtime? : Yes
- Scorecard Category : Engineering
- Commercial Title : Sr. Quality Assurance Engineer
- Vaccination Notice : This position requires Contingent Workers to be fully vaccinated against COVID-19 unless they are granted a medical or religious exemption.
- Is this position for a pre-identified (PAYROLLED) candidate? : RECRUITED
- If this is a pre-identified (PAYROLLED) candidate, please see note below and provide the following: : Name: Email Address: Phone Number: Pay Rate: Please also attach the pre-identified candidate's resume
- Will this contingent worker require a computer or systems access or utilize a timeclock? : Yes
- Time System : Fieldglass
- Timeclock/Shift : Fieldglass|1
- Enter Shift Start and End Time : 9 am-5 pm, but flexible for core hours (8 am-4 pm or 10 am to 6 pm)
- Is there potential for this to convert to a full time position? : Yes
- Non-Employee Class : Temporary Agency Worker
- Will the worker be required to travel? : No
- Is there potential for this assignment to be extended beyond 13 weeks? : No
- Type of assignment : Full-time
- Will this position require a DEA background check clearance? : No
- Healthineers Vaccination Statement : Healthineers positions within applicable states require candidates to be fully vaccinated or obtain approval of special medical or religious exemption within three days of worker start date.Currently not applicable in the following states: Alabama, Florida, Iowa, Kansas, Montana, North Dakota, Tennessee, Texas, and Utah. States subject to change
Job Summary
Full Time
IT Outsourcing & Consulting
$116k-139k (estimate)
06/12/2024
12/07/2024
apninc.com
NEWARK, CA
25 - 50
1996
Private
ASLAM CHANDIWALLI
$10M - $50M
IT Outsourcing & Consulting
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