Watertown, United States
3 months ago
Lighthouse Professional Services, a division of Staffing 360 Solutions group of companies, has been providing contract and direct hire talent to client companies, ranging from small businesses to Fortune 500 corporations for over 50 years. Our offices are in New York, Connecticut, and Massachusetts, and we work with clients across the country. Our management and recruiting teams are led by experienced industry professionals. We invest in excellent working partnerships, powered by people.
Lighthouse Professional Services committed to the success of the companies, candidates, and employees we serve. We invest in excellent working partnerships, powered by people.
We are currently seeking a Quality Manager in Watertown, MA.
Essential Functions & Responsibilities (Other Functions May Be Assigned)
- Maintains the compliance status of the company with respect to quality system certifications to ISO 13485:2016, MDSAP, EN ISO 13485:2012, Canadian Requirements and Medical Device Directive Annex II.· Maintains and enhances processes to ensure quality system compliance with the FDA Quality System Regulation (21 CFR Part 820, Part 803, Part 11).
- ISO Management Representative and MDR Qualified Person.
- Oversees the scheduling, performance and responses to internal and external audits.
- Manages the company CAPA system.
- Supports Management Team to accomplish product cost (COG) reduction and incremental profitability of the company without sacrificing quality and integrity of the product.
- Leads Management Review meetings.
- Oversees, maintains, and creates Quality System documentation and regulatory files.
- Participates in decision-making team relating to Medical Device Vigilance, MDR’s, product recalls and issuance of Advisory Notices, if required.
- Reviews and approves validation activities.
- Leads Incoming Inspection, Document Control and Supplier Quality functions.
Qualifications / Experience Requirements
- Minimum of 3-5 years as a manager of QA/RA at a medical manufacturing company with an appreciation for the requirement of meeting customer delivery requirements.
- Working knowledge of current FDA Quality Systems Regulation, Canadian MDR, ISO 13485 versions, Australian regulations and the EU Medical Device Regulations. Other countries may become necessary.
- Experience with devices containing both hardware and software components.
- Experience with 21 CFR Part 11 Electronic Systems preferred.
- Excellent communication, interpersonal, time management, and leadership skills.
- Must have a “how can we get it done,” rather than a “why we can’t do it” approach.
- We require someone willing to roll up their sleeves to get things done and not merely to pontificate and/or to direct the actions of others.
- Appropriate quality certifications preferred.
- Required education: Bachelor's in Engineering.
Qualified candidates are encouraged to apply immediately!
Please include a clean copy of your resume and salary expectations.
Submit resumes to: Sherrine.email@example.com