Quality Assurance Team Lead

JR United Kingdom; Plymouth; On-site; GBP 40,000 - 70,000; Full time

Job summary

Ein innovatives Unternehmen sucht einen Qualitätsingenieur, der für die Qualitätssysteme und -prozesse verantwortlich ist. In dieser Schlüsselrolle sind Sie für die Führung des Qualitätsteams verantwortlich, um sicherzustellen, dass alle Produkte den höchsten Standards entsprechen. Sie werden an der Schnittstelle zwischen Design und Produktion arbeiten, um sicherzustellen, dass alle Produkte sowohl herstellbar als auch zuverlässig sind. Wenn Sie eine Leidenschaft für Qualität und Compliance in der Medizintechnik haben und in einem dynamischen Umfeld arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Qualifications

• Mindestens 4 Jahre Erfahrung in der Medizintechnik oder Pharmaindustrie.
• Erfahrung in Qualitätsengineering und -systemen ist erforderlich.

Responsibilities

• Leitung des Qualitätsteams und Sicherstellung der Einhaltung von Standards.
• Kommunikation von GMP an R&D- und Produktionsmitarbeiter.

Skills

Qualitätsengineering

Qualitätssysteme

GMP

Risikobewertung

Statistische Analyse

Kommunikationsfähigkeiten

Education

BS oder gleichwertig in wissenschaftlicher Disziplin

Tools

Microsoft Word

Microsoft PowerPoint

Microsoft Excel

Job description

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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.

Responsible for the Quality Engineering and Quality Systems functions. To manage the day-to-day activities of the Quality Engineering and Systems functions to ensure compliance to relevant standards, regulations and internal processes and the continued suitability, adequacy and effectiveness of the AMS Quality System.

What will this role involve?

• Day to day management of the Quality Engineering team, providing coaching and ensuring site requirements are met from the function.
• Day to day management of the Quality Systems team, providing coaching and ensuring site requirements are met from the function.
• Accountable for the representation of Quality Engineering and Quality Systems through all product design and development life cycle phases to help ensure product manufacturability, reliability and cost effectiveness.
• Ensures timely response to customer complaints, when necessary, acts as customer liaison to the quality team, and ensures customer satisfaction in response to detected non-conformances.
• Communicates and influences implementation of current and applicable good manufacturing practices (GMP) (e.g.: ISO13485 / 21 CFR Part 820 / MDR) to R&D team, Manufacturing and other Operations staff as applicable.
• Creates, reviews and approves documentation associated with the AMS quality system including but not limited to quality plans, verification/validation protocols, risk assessment documentation and updates to quality system and department procedures.
• Attends, and where required, facilitates regular communication meetings with cross-functional teams to identify the root cause of problems and create remedial plans for short-term and long-term resolutions.
• Responsible for assigned change control activities and document management requirements by collaborating with applicable departments and peers to define change control activity requirements for individual projects.
• Attends change control review board as SME.
• Participates in risk evaluations, using tools such as Process/Design Failure Mode and Effects Analysis (PFMEA /DFMEA) associated with the PDP process.
• Review and approve risk management documentation.
• Troubleshoots problems for continual improvement.
• Monitor and maintain KPIs for the Quality Engineering and Quality Systems functions. Implements improvement initiatives to reduce the KPIs and return to target where required. Effectively communicate KPI status to the Quality Manager.
• Involved in internal and external audits.
• Perform other related duties as assigned

What we're looking for?

• BS or equivalent in scientific discipline or the abilities that are typically acquired through a minimum of 4 years’ experience in medical device or pharmaceutical industries.
• Proven experience in Quality Engineering and/or Quality Systems processes.
• Ideally the candidate would have experience of managing direct reports.
• Must have knowledge of QA, Manufacturing, Validation, Change Control, and Design Control processes.
• Must be proficient in the knowledge of applicable Quality System Regulations and ISO quality requirements.
• Proficient in concepts of statistics, sampling plans and statistical analysis.
• Ability to independently plan, execute, and/or problem solve moderate to complex situations.
• Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Solid oral and written communication skills.
• Ability to manage multiple projects.
• Good written and oral communication skills are required, for example to ensure succinct report generation, effective communication with staff, peer groups, etc. across organisation.
• Computer literate - knowledge of Word, PowerPoint and Excel an advantage - to produce reports, analyse data etc. effectively.