CMR Surgical on cord

CMR Surgical

Quality Engineer

External position
Ely, UK
Hiring internally for CMR Surgical?
MedTech · Robotics
Transforming surgery. For good.
Posted
2 months ago
Checked
cord regularly checks that external positions are still open
2 days ago

Skills & Experience

Job roles: Quality Assurance
Experience level: Senior
Core skills considered: Process management, Project Management
Other skills considered: Auditing, Data Analysis

Logistics

Base salary: Undisclosed
Some companies on cord are unable to disclose salaries publicly due to internal company policies. Message the company for salary information.
Employment type: Permanent
Remote working: On-site
Visa sponsorship: Not available

Job Description

You 9ll be part of a close-knit and dynamic Operations Quality team. Overall responsible for driving Quality Engineering (QE) mindset to continually improve Operation processes. These are (primarily) but is not limited to Process Validation e.g. creating/approving protocols & reports, maintenance of SMVP; and QE core tools e.g. Statistical Process Control (SPC), Measurement System Analysis (MSA), pFMEA, Control Plan as well as (secondary) NCRs, DOA, CAPA e.g. managing, analysing data, driving improvements and effectiveness of Corrective & Preventative Actions, reporting metrics / KPIs / dashboard (landscape, visibility). This is a full-time, permanent on-site role based at CMR Surgical Ely site. The role is primarily site-based due to the need to support Operations Quality, manufacturing processes, investigations, audits and cross-functional activities, in line with business needs and company policy. The role does not currently have direct line management responsibility but will require strong cross-functional influence and collaboration across Operations, Quality, Supplier Engineering, Technology and other relevant teams. Occasional travel may be required to support suppliers, audits, training or other business needs. This role is based on-site at our Ely premises.


Responsibilities

  • Process Validation - owns this remit across the Operation team.
  • Maintenance of site master validation plan (SMVP) and Process Validation procedure including update, streamlining, compliance to CMR QMS and regulatory requirements e.g. ISO 13485 and medical device / pharmaceutical best practices.
  • Creates, reviews, approves templates, protocols and reports e.g. master validation plan, URS, FAT, SAT, IQ, OQ, PQ in collaboration with SMEs.
  • Support and collaborates with Operation team e.g. validation strategy and lifecycle deliverables, documentations, etc.
  • QE core tools (SPC, MSA, FMEA, Control Plan) - leads, implements, streamlines, improves, and collaborates with SMEs.
  • To address Operation current and future needs including continuous improvements as well QMS requirements e.g. NCR, DOA, CAPA, SCAR.
  • Creates, updates, reviews, approves, streamlines templates and procedures to meet CMR QMS and regulatory requirements e.g. ISO 13485 and medical device / pharmaceutical best practices.
  • NCR / DOA / CAPA - supports (primarily) or/and leads, manages the day-to-day cadence e.g. Triage; MRB NCR Review Board (NCRB); NCR Clinic; timely progression and closure against relevant metrics.
  • Collaborates with key stakeholders for timely progress of NCR / DOA / SCAR (when needed) e.g. writing up (updating) Containment Action, Corrective Action, Preventative Action, Investigation (RCA) as well as ensuring effectiveness of actions.
  • Analyses data, publishes reports (metrics) KPIs, and proactively drives actions for NCR / DOA / CAPA / SCAR e.g. overall status / landscape; progress and timely closure; Pareto analysis of key issues; reduction / preventing recurring and systemic issues; identify areas for improvement; NCR escalation to CAPA.
  • Manages and collaborates with key stakeholders the visibility, drive timely closure and effectiveness of actions for Operation and Operation-Quality related CAPAs.
  • Review and approval (closure) of NCR / SCAR / DOA.
  • Generates, reviews / approves MCR, CN, Concession (Deviation), QMS documentation (QP, WI, QD) to support Operation, Operation-Quality, and other relevant stakeholders.
  • Supports internal and external / 3rd party audits as well as ensuring compliance with relevant regulations and industry standards.
  • Covers Quality Engineer and Operation Quality Manager function when needed (e.g. holidays) - CRB, NCR / DOA / CS / QMS documentation approvals; management of the team, etc.

Essential Skills:

  • Process Validation - end-to-end (URS-to-PQ) including writing, review, and approval of protocols and reports and lifecycle deliverables e.g. URS, master validation plan, site master validation plan, validation deviation.
  • Quality Engineering core tools (SPC, MSA, pFMEA, Control Plan) - implementation (roll out) e.g. from concept to execution including training and mentoring of SMEs; writing MSA (GR&R) protocols and reports,
  • Regulated environment - proven experience and understanding of MDSAP, ISO 13485, MDR / MDD, UKCA, GMP (Pharma).
  • Statistical analysis including use of statistical tools / software (Minitab, JMP).
  • High proficiency in MS Office tools.

Desirable Skills:

  • NCR / CAPA / DOA / SCAR - leading / implementing / facilitating timely progress including root cause analysis (RCA) tools e.g. WHY-WHY analysis, Fishbone, Fault Tree Diagram as well as problem solving tools e.g. 8D.
  • QMS and ERP software - experience with PowerBI; Netsuite / SAP; and e-QMS (e-DMS) e.g. Qualio, Greenlight Guru, Veeva, ComplianceQuest, IQVIA SmartSolve.
  • Lean/Six Sigma (Green or Black Belt) in process improvement (manufacturing / operation).
  • Internal/Lead Auditor trained to ISO 13485.
  • Quality Plan - use & implementation in conjunction with QMS processes e.g. change control.
  • Project management - including escalation process, resource management, etc.

About you

  • Continually challenge status-quo and drive continuous improvement mindset to meet business current and future needs e.g. efficiency, having practical (pragmatic, sustainable) processes and systems without compromising Quality (patient safety).
  • Fosters a culture of continuous improvement and quality-focused (engineering) mindset.
  • Attention to detail, integrity, organisation, communication, and interpersonal, clerical and computer skills.
  • Effective communicator who can confidently engage with various stakeholders.
  • Creative / methodological / pragmatic approach to problem solving (Investigation, RCA).
  • Resilient and comfortable working in a fast-paced working environment, or by a wide range of tasks.
  • Professional and good team player.

Qualifications:

  • Minimum of Degree or equivalent in a science, engineering or similar subject.
  • Typically, 5 years' Quality Engineering experience in medical devices, pharmaceutical, healthcare.

Relevant transferable experience and the potential to develop into the full scope of the role will be considered, even if candidates do not meet every listed requirement. We'd expect you to be willing to turn your hand to anything within the Operations Quality remit that helps the team deliver its objectives.

Quality Engineer at CMR Surgical
Position posted 2 months ago

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Starling Bank on cord

Starling Bank

Full Stack Engineer (ML Ops)

London, UK
FinTech · Banking · Finance
A better bank for everyone
Active
over 6 months ago
Responds to
0% of requests
Responds in
1h 55m
Requests
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Skills & Experience

Job roles: Full Stack
Experience level: Mid, Senior
Core skills considered: Java, React, Redux, AWS, JavaScript

Logistics

Base salary: £70K - £110K
Employment type: Permanent
Remote working: Hybrid (up to 2 remote days p/w)
Visa sponsorship: Not available

Job Description

Starling is the UK’s first and leading digital bank on a mission to fix banking! Our vision is fast technology, fair service, and honest values. All at the tap of a phone, all the time.

Starling is the UK’s first and leading digital bank on a mission to fix banking! We built a new kind of bank because we knew technology had the power to help people save, spend and manage their money in a new and transformative way.

We’re a fully licensed UK bank with the culture and spirit of a fast-moving, disruptive tech company. We’re a bank, but better: fairer, easier to use and designed to demystify money for everyone. We employ more than 3,000 people across our London, Southampton, Cardiff and Manchester offices.

Our technologists are at the very heart of Starling and enjoy working in a fast-paced environment that is all about building things, creating new stuff, and disruptive technology that keeps us on the cutting edge of fintech. We operate a flat structure to empower you to make decisions regardless of what your primary responsibilities may be, innovation and collaboration will be at the core of everything you do. Help is never far away in our open culture, you will find support in your team and from across the business, we are in this together!

The way to thrive and shine within Starling is to be a self-driven individual and be able to take full ownership of everything around you: From building things, designing, discovering, to sharing knowledge with your colleagues and making sure all processes are efficient and productive to deliver the best possible results for our customers. Our purpose is underpinned by five Starling values: Listen, Keep It Simple, Do The Right Thing, Own It, and Aim For Greatness.

Hybrid Working

We have a Hybrid approach to working here at Starling - our preference is that you're located within a commutable distance of one of our offices so that we're able to interact and collaborate in person. We don't like to mandate how much you visit the office and work from home, that's to be agreed upon between you and your manager.

Our Data Environment

Our Data teams are excited about the value of data within the business, powers our product decisions to improve things for our customers and enhance effective and agile decision making, regardless of what their primary tech stack may be. Hear from the team in our latest blogs or our case studies with Women in Tech.

We are looking for talented data professionals at all levels to join the team. We value people being engaged and caring about customers, caring about the code they write and the contribution they make to Starling. People with a broad ability to apply themselves to a multitude of problems and challenges, who can work across teams do great things here at Starling, to continue changing banking for good.

Requirements

We have built our entire banking platform in house and mostly in Java. We are looking for people who want to work on building the tooling that is used by our engineers on a daily basis.

We are looking for people who are truly full stack, and are as comfortable polishing their javascript front end as they are debugging the innards of their java applications database interactions, or standing up infrastructure with terraform. We are looking for people who can:

  • Design REST apis.
  • Code backend services, ideally using Java, or another other server side compiled language.
  • Develop modern front ends, ideally using React and Redux.
  • Get their code into the cloud and support it there, ideally on AWS.
  • Believe in clean coding, simple solutions, automated testing and continuous deployment.
  • Like to take ownership of a feature from the original idea through to live.
  • Think (like us) that a small number of empowered developers is the right way to deliver software.

Company Benefits

  • 33 days holiday (including flexible bank holidays)
  • An extra day’s holiday for your birthday
  • 16 hours paid volunteering time a year
  • Part-time and/or flexible hours available for most roles
  • Salary sacrifice, company enhanced pension scheme
  • Life insurance at 4x your salary
  • Hybrid/remote working
  • Private Medical Insurance with VitalityHealth including mental health support and cancer care. Partner benefits include discounts with Waitrose, Mr&Mrs Smith and Peloton
  • Generous family-friendly policies
  • Varied social groups set up and run by our employees
  • Perkbox membership giving access to retail discounts, a wellness platform for physical and mental health, and weekly free and boosted perks
  • Access to initiatives like Cycle to Work, Salary Sacrificed Gym partnerships and Electric Vehicle (EV) leasing

Full details are available on our careers site

Interview Process

Interviewing is a two way process and we want you to have the time and opportunity to get to know us, as much as we are getting to know you! Our interviews are conversational and we want to get the best from you, so come with questions and be curious. In general you can expect the below, following a chat with one of our Talent Team:

  • Stage 1 - 30 mins with one of the team
  • Stage 2 - Take home challenge
  • Stage 3 - 90 mins technical interview with two team members
  • Stage 3 - 45 min final with an executive and a member of the people team
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