13 Jobs in Franklin, MA
GCX Healthcare Solutions is Hiring a Quality Systems Specialist Near Franklin, MA
Provide Quality Engineering support to ensure the successful development and continual improvement of GCX Mounting Solutions products. This individual will be expected to apply his/her knowledge of Design Control principles and quality engineering techniques to positively collaborate in product development efforts. In parallel, the candidate shall also ensure the products are developed and manufactured in accordance with applicable company policy, industry standards, and regulatory requirements
- Lead and participate in the development, implementation, and maintenance of quality programs, systems, and procedures (e.g., CAPA, Change Control, Audits).
- Independently conduct and participate in internal quality audits, analyzing findings and leading corrective action activities.
- Analyze quality system data, identify trends, and recommend and implement QMS improvement initiatives.
- Maintain and update complex quality system documentation, ensuring accuracy and compliance with regulations.
- Provide subject matter expertise and guidance to colleagues on quality system policies, procedures, and regulations.
- Support the implementation and effectiveness of quality training programs.
- Take ownership of managing CAPA and customer complaints, driving resolution and preventing recurrence.
- Lead risk management activities within assigned areas, identifying, assessing, and mitigating risks to the QMS.
- Manage and participate in cross-functional projects related to quality systems.
- Travel requirements: 25%
- Bachelor's degree (B.S.) required.
- Minimum 2 years of experience in a quality systems role, preferably within the medical device industry.
- Prior experience working in a regulated industry (FDA, GMP) preferred
- 13485 Lead Auditor / Green Belt certification preferred
- Understanding and proven experience applying relevant quality standards (e.g., ISO 13485, FDA QSR).
- Excellent analytical and problem-solving skills with a demonstrated ability to identify root causes and implement effective solutions.
- Outstanding communication and interpersonal skills, with the ability to effectively train, mentor, and collaborate with colleagues at all levels.
- Proven ability to work independently, manage multiple priorities, and meet deadlines.
- Proficient in Microsoft Office Suite and familiar with quality system management software.
- Prior experience working in medical device industry and with product submissions to regulated bodies (e.g., FDA) preferred
- Project Management skills preferred
- Commitment to excellence and high standards
Job Summary
Full Time
$106k-130k (estimate)
04/03/2024
06/02/2024
The job skills required for Quality Systems Specialist include Problem Solving, Project Management, Microsoft Office, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Systems Specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Systems Specialist. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Quality Systems Specialist positions, which can be used as a reference in future career path planning. As a Quality Systems Specialist, it can be promoted into senior positions as a Business Application Delivery Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Systems Specialist. You can explore the career advancement for a Quality Systems Specialist below and select your interested title to get hiring information.
If you are interested in becoming a Quality Systems Specialist, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Quality Systems Specialist for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on Quality Systems Specialist job description and responsibilities
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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Quality Systems Specialist jobs
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Step 3: View the best colleges and universities for Quality Systems Specialist.
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