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Head of Global Recruitment at Advanced Medical Solutions
Quality Manager – Vitalitec, Plymouth, Massachusetts.
Who are Advanced Medical Solutions?
AMS is a world-leading independent developer and manufacturer of innovative tissue-healing technology, focused on quality outcomes for patients and value for payers. AMS has a wide range of surgical products including tissue adhesives, sutures, haemostats, internal fixation devices and internal sealants, which it markets under its brands LiquiBand, RESORBA, LiquiBandFix8, LIQUIFIX, Peters Surgical, Ifabond, Vitalitec and Seal-G. AMS also supplies wound care dressings such as silver alginates, alginates, and foams through its ActivHeal brand as well as under white label. Since 2019, the Group has made seven acquisitions: Sealantis, an Israeli developer of innovative internal sealants, Biomatlante, a French developer and manufacturer of surgical biomaterials, Raleigh, a leading UK coater and converter of woundcare and bio-diagnostics materials, AFS Medical, an Austrian specialist surgical business, Connexicon, an Irish tissue adhesives specialist, Syntacoll a German specialist in collagen-based absorbable surgical implants and Peters Surgical a global provider of specialty surgical sutures, mechanical haemostasis and internal cyanoacrylate devices. AMS's products, manufactured in the UK, Germany, France, the Netherlands, Thailand, India, the Czech Republic and Israel, are sold globally via a network of multinational or regional partners and distributors, as well as via AMS's own direct sales forces in the UK, Germany, Austria, France, Poland, Benelux, India, the Czech Republic and Russia. The Group has R&D innovation hubs in the UK, Ireland, Germany, France and Israel. Established in 1991, the Group has more than 1,500 employees. For more information, please see www.admedsol.com
AMS provides equal employment opportunities for all applicants. We highly value and encourage diversity across our workforce meaning that no one will be discriminated against because of their gender, race, age, nationality, disability, or any other protected characteristic as prohibited by law.
The Quality Assurance Manager defines and coordinates the implementation of the company's quality policy and objectives (methods, organization, process, audits) to guarantee the quality and compliance of the medical devices marketed, for product and supplier quality assurance. He/she participates in the continuous improvement of the company's quality management system and ensures compliance with standards and the maintenance of certifications.
Breaks down the policy and objectives applicable to its scope into a strategic action plan and objectives for its team. Submits the strategic action plan and the objectives he/she has defined to his/her manager for validation. Has a certain latitude in the organization of his entity and the evolution of procedures. Reports on its activity on a regular basis (monthly or quarterly) and submits strategic decisions to the validation of its manager. Its activity is evaluated according to the achievement of the objectives set.
Specifically:
* 10-20% travel.
* On site in Plymouth, MA
What will this role involve?
* Participates in professional relations with administrative authorities and answers questions about quality audits.
* Ensures the planning and implementation of supplier quality audits.
* Participates in customer audits, Notified Body audits and Competent Authority inspections.
* Ensures the management with suppliers/subcontractors (quality agreement, follow-up, evaluation).
* Ensures the implementation and follow-up of quality, preventive or corrective actions.
* Ensures the implementation and monitoring of Change Control.
* Ensures the management of suppliers/subcontractors.
* Ensures the management of complaints.
* Ensures the implementation and follow-up of non-conformities and rework.
* Participates in the promotion of the quality approach internally and with external partners.
* Ensures the establishment of document management rules, their application and the updating of Quality.
* Define a representative in other business activities requiring service verification/approval.
* Ensures that routine checks are carried out in accordance with quality system documents.
* Ensures that products are sampled, placed in sample banks and monitored.
* Ensures that orders for tests outsourced to external laboratories are carried out and the reports approved.
* Drafts non-conformity sheets for recording.
* Authorises the release of finished products onto the market.
* Defines or manages a budget within its scope.
* Plans the activity in the short and medium term, defines priorities according to the challenges and risks, with regard to the orientations defined by the management.
* Proposes organizational changes when necessary.
* Manages contingencies with agility, implements an appropriate action plan, if necessary.
* Analyzes and manages operational performance.
* Designs and implements a continuous improvement plan.
* Ensures compliance with company rules.
* Ensures the reporting of the activity
What we're looking for?
* Education/qualifications required: Bac + 5 in the field of quality or scientific field with 7 years of experience.
* Knowledge of standards and regulations: ISO 13485:2016, MDR (UE 2017/745), MDD, 21 CFR part 820 and part 11.
* Soft skills: Initiative and autonomy, versatility, ability to manage time and priorities, rigor and sense of responsibility, team spirit, openness to others, professional ethics, ability to lead a team
* French language skills a plus.
Seniority level
* Seniority level
Associate
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance and Science
* Industries
Pharmaceutical Manufacturing
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Inferred from the description for this job
Medical insurance
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