Senior Quality Assurance Engineer - 3284
Remote (EST), MA 02451 US
Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.
Title: Senior Quality Assurance Engineer
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration: 5+ month contract
- Pay rate: $65 – $69.04/hr
- Job Location: Remote, may require up to 10% travel to Boston, MA & Shelton, CT
- Schedule: Standard business hours
- Job#: bh14966
Senior Quality Assurance Engineer
In order to set expectations and to the extent permitted by applicable law, please note that if an applicant is hired for this position, the applicant will be required to prove that the applicant has been fully vaccinated against COVID-19 by the date of hire, subject to any qualified religious or medical exemptions. Please note that the employer reserves its rights to mandate additional vaccine requirements at any time.
Primary job responsibilities include ownership of key quality systems supporting daily operations, continuous improvement projects, CAPA management, and change control.
Duties and responsibilities/essential functions:
- Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and regulations.
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Responsible for driving quality programs, continuous improvement projects, and CAPA investigations and solutions to ensure appropriate measures are implemented to prevent recurrence
- Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of audits.
- Supports the NCMR programs and ensure appropriate disposition of nonconforming parts
- Supports all departments to ensure timely root cause identification for process/product deviations; may organize, facilitate and document Material Review Board activities.
- Utilizes standard statistical analysis techniques to evaluate process capability; provides technical guidance and training to other team members in statistical analysis techniques: experimental design, data analysis, sampling techniques and other traditional QA Engineering activities.
- Drives site validation and equipment qualification programs; routinely involved with generation, review and/or approval of IQ, OQ, PQ protocols and reports.
- Review device history records and release product
- Acts as the QA representative on Design Services Projects supporting new product introductions, qualification of new suppliers, development and approval of new product documentation.
- Develop and maintain documentation in compliance with FDA, ISO, MDR, IVDR requirements
- Other duties as assigned
- Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any time.
- Bachelor’s or master’s degree in Engineering, Science, manufacturing engineering, quality engineering, life science, or related field (will consider candidates in other degree areas with supplemental work history in quality engineering)
- Continuous improvement experience preferred (6 Sigma, Lean, GreenBelt/Black Belt)
- Lead or Internal Auditor Certification to ISO 13485 (nice to have)
- 5+ years of related work experience, working in a regulated environment within the IVD or Medical Devices industry (or life sciences)
- Expertise in CAPA and investigation techniques.
- Auditing experience to 21CFR820, ISO 13485, ISO 14971, MDD, and MDSAP.
- Familiar with product safety and product specific industry standards
- Experience in project management.
- Demonstrated ability to work effectively and positively with all levels of an organization.
- Capable of working both independently and in a team setting; team oriented and committed to continuous improvement.
- Proficient skills with Microsoft Office (Word, Excel, PowerPoint)
- Strong organization skills.
- Excellent communication skills
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
When responding to this job posting you MUST include the Job# and Job Title in your subject line.
If you are active in a job search but this job is not for you, please reach out to email@example.com. We would be glad to help you find the perfect job!