What are the responsibilities and job description for the QA Engineer II position at Apex Systems?
Job Description
Job#: 1342978
Job Description:
**Apex Systems is looking for a QA Engineer Role in the Linwood, PA area**
If interested please send your resume to Tessa Moore
Job Title: QA Engineer
Contract Length: 6 months, high possibility of extension
Location: Linwood, PA
Job Type: Hybrid, at least 3 days in office, needs to be in Linwood more than half the time
Job Description:
• Responsible for structured analysis of product safety/compliance incidents in the market (including initiating follow up) and ensures remediation.
• Ensures BG/local commitment to product safety/compliance and signs off declarations on product safety/compliance and compliance on behalf of BG/site management.
• Leads all product safety/compliance related activities in the SVAL/BG/Site to interpreted, products comply with all regulatory requirements and Philips safety/compliance incident handling process including review and decision making on product safety/compliance related escalations.
• Ensure proper root cause analysis in case of product safety/compliance non compliances according to regulations and/or the 8D methodology.
• Ensures (support/consultation) proper reflection of all the relevant regulatory requirements in all projects, OEM ODM products, including lifecycle management and verify and validate designs regarding these requirements.
• Makes and/or validates independent product safety risk assessments in line with conflict-of-interest rules & regulatory standards.
• Reports and discusses trends in product roadmaps with Regulatory Affairs and Standards team that may require pro-active lobbying, building up of knowledge about new requirements and/or new relationships with authorities.
Skills:
• Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
• Qualified expert who is developing beyond entry level knowledge of the quality engineering field.
• Has working knowledge of products and services.
• Frequently interacts with supervisions and functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules.
• Basic understanding of global medical device regulations, requirements, and standards, such as 21 CFR Parts 803,806, and 820, ISO13485, and ISO9001
Education:
1-3 years exp. Of related experience in a medical device or non-regulated industry
Bachelor of Engineering or another STEM-based degree
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .
Job Description:
**Apex Systems is looking for a QA Engineer Role in the Linwood, PA area**
If interested please send your resume to Tessa Moore
Job Title: QA Engineer
Contract Length: 6 months, high possibility of extension
Location: Linwood, PA
Job Type: Hybrid, at least 3 days in office, needs to be in Linwood more than half the time
Job Description:
• Responsible for structured analysis of product safety/compliance incidents in the market (including initiating follow up) and ensures remediation.
• Ensures BG/local commitment to product safety/compliance and signs off declarations on product safety/compliance and compliance on behalf of BG/site management.
• Leads all product safety/compliance related activities in the SVAL/BG/Site to interpreted, products comply with all regulatory requirements and Philips safety/compliance incident handling process including review and decision making on product safety/compliance related escalations.
• Ensure proper root cause analysis in case of product safety/compliance non compliances according to regulations and/or the 8D methodology.
• Ensures (support/consultation) proper reflection of all the relevant regulatory requirements in all projects, OEM ODM products, including lifecycle management and verify and validate designs regarding these requirements.
• Makes and/or validates independent product safety risk assessments in line with conflict-of-interest rules & regulatory standards.
• Reports and discusses trends in product roadmaps with Regulatory Affairs and Standards team that may require pro-active lobbying, building up of knowledge about new requirements and/or new relationships with authorities.
Skills:
• Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
• Qualified expert who is developing beyond entry level knowledge of the quality engineering field.
• Has working knowledge of products and services.
• Frequently interacts with supervisions and functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules.
• Basic understanding of global medical device regulations, requirements, and standards, such as 21 CFR Parts 803,806, and 820, ISO13485, and ISO9001
Education:
1-3 years exp. Of related experience in a medical device or non-regulated industry
Bachelor of Engineering or another STEM-based degree
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .
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