Quality Engineer

1 month ago

Winsford, United Kingdom Emprego UK Full time

About AMS

**Who are Advanced Medical Solutions?**

When we say we're a world leading independent developer and manufacturer of innovative and technologically advanced products for the global advanced wound care, wound closure and surgical markets, it's true. But we're much more than that...

With over 800 employees across the globe, we pride ourselves on being able to create an engaging and challenging place of work, developing individuals to the best of their abilities, and providing the correct environment to foster innovation, growth and meaningful work.

We're highly dependent on the creativity of our employees for our future growth and success. Our motto **'Care, Fair, Dare'** summarises our culture, and defines the principles of how we operate as one team to achieve success.

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.

Job Details
Responsible for support to the Quality Engineering function.

Key responsibilities

**Key Responsibilities**
- Responsible for the representation of Quality Engineering through all product design and development life cycle phases to help ensure product manufacturability, reliability, and cost effectiveness.
- Communicates 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.
- Create and review documentation associated with the AMS quality system including but not limited to quality plans, verification/validation protocols, risk assessment documentation, complaint reports and updates to quality system and department procedures.
- Responsible for defining requirements of verification/validation protocols, technical investigations plans, reports and related procedures which ensure statistical validity, adequacy, and compliance to regulatory and Group requirements.
- Attend 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, ensuring an adequate level of containment and investigation has been performed.
- Supports 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.
- Facilitates and performs in complaint investigation and acts as AMS quality representative working with the customer for timely resolution of open complaints.
- Review and approve risk management documentation.
- Troubleshoots problems for continual improvement.
- To lead by example in all areas of GMP and quality compliance.

**What we're looking for**:

- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- BS or equivalent in scientific discipline or the abilities that are typically acquired through a minimum of 2 years' experience in medical device or pharmaceutical industries.
- Must be proficient in the knowledge of applicable Quality System Regulations and ISO quality requirements.
- Must have knowledge of QA, Manufacturing, Validation, Change Control, and Design Control processes.
- Proficient in concepts of statistics, sampling plans and statistical analysis.
- Proficient in analytical methods, equipment, process, software, cleaning and/or facility/utility validations.
- 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 and changing priorities.
- Good written and oral communication skills are required, for example to ensure succinct report generation, effective communication with staff, peer groups, etc. across organisation.
- Supports activities associated with aspects of the Quality Management System including:

- Status of Non-Conformances and CAPAs.
- Participation in Material Review Board (MRB).
- Participation in compliance meetings.
- Performs internal audits if required.
- Perform other related duties as assigned.
Employment BasisFull Time Location CountryUnited Kingdom Location CityWinsford Applications Close Date30 Jun 2023

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