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Quality Assurance Engineer
300 Unicorn Park Drive Woburn, MA 01801 US
Job Description
POSITION TITLE:
Quality Assurance Engineer
SCOPE:
The role provides Quality Engineering support in the execution of manufacturing and risk management deliverables associated with new and existing products to meet global medical device regulations. The role also provides Quality Engineering support to complaint handling, design controls, and supplier-related activities associated with new and existing products.
PRIMARY RESPONSIBILITIES:
- Serve as Quality Engineering representative ensuring that design and manufacturing related activities are completed and comply with global medical device regulations (e.g., FDA, EU, etc.) and internal Quality System requirements.
- Conduct risk assessments and implement risk management strategies to address potential quality issues throughout the product lifecycle.
- Support root cause analysis and corrective action processes for non-conformities, including the development and implementation of preventative measures.
- Generate and ensure compliant completion of Quality deliverables, including change requests, risk management deliverables, test methods, process validation, packaging and labeling documentation, SOPs, and manufacturing work instructions. Ensure all documentation is accurate and up to date.
- Assist with internal and external audits to assess the effectiveness of the quality management system and ensure compliance with regulatory and company standards.
- Provide key quality trending information and data for use in periodic reviews.
- Investigate customer complaints and analyze feedback to identify trends and drive improvements to product quality and customer satisfaction.
- Evaluate and monitor suppliers for quality performance. Collaborate with suppliers to address and resolve quality issues.
- Be flexible and work within a small team without strictly defined roles to assure complete functional coverage.
EDUCATIONAL PREREQUISITES AND SKILL REQUIREMENTS:
- BS in STEM (Science, Technology, Engineering, Mathematics).
- 3–5 years of Quality Engineering experience in the medical devices or pharmaceutical industry with demonstrated competency of 21 CFR 820, EU MDR, EN ISO 13485, and EN ISO 14971.
- Strong communication and presentation skills; energetic, proactive, and flexible with high integrity and ethics in all dealings.
- Competent in Microsoft Office Suite and Minitab Statistical Analysis software (or equivalent).
- Ability to prioritize, focus, collaborate, and work effectively in a fast-paced and dynamic cross-functional environment.
TRAINING REQUIREMENTS:
- Undergo all formal Training Events as directed.
- Observe and comply with all Corporate Policies.
- Work within, and ensure adherence to Quality System procedures, work instructions, and other Quality System requirements.
- Work within, and ensure adherence to Health, Safety and Environment Management System procedures, instructions, and other requirements.
Compensation will be determined based on individuals qualifications
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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