Job Title: Quality Assurance Officer (12 Months Maternity Cover)
Location of Work: Solihull (Blink Medical)
Employment Type: Full Time Employee
Job Description
Reports to: Quality Assurance Director
Our mission
At Corza Medical, our mission is to champion surgical providers with remarkable service and exceptional products that save time, money, and effort. We are a passionate team guided by our core belief that you should never have to choose between performance, value, and a quality customer experience. We are here to support you every step of the way.
Our brand promise
We deliver a collaborative experience by working directly with the surgical community to ensure you get the exact surgical tools you need at the right time and the right price.
1. Remarkable service: A seamless, personal process designed around you and your needs.
2. Trusted performance: Our product family is the result of years of experience championing surgeons and listening to their expertise.
3. Outstanding value: No matter the surgical specialty, we deliver quality products for all markets.
Our people promise
Excellence is our Specialty and what makes us successful is our people. We are committed to fostering a positive, empowering and growth-oriented environment where all team members are encouraged to share their opinions and ideas.
Job Purpose Summary
The role will be part of the Quality Assurance team (as part of the Blink Medical Quality Department), focused on providing quality & regulatory assurance support in-line with business needs for the single use surgical instruments and procedure packs manufactured and placed on the market by Blink Medical.
The role will be responsible for supporting the routine management & continuous improvement of the Blink Medical Quality Management System in accordance with the latest requirements of ISO 13485:2016 and all other applicable regulatory requirements (where Blink Medical places product on the market) including EU MDD 93/42/EEC; EU MDR 2017/745; UK MDR 2002 (SI 618) & FDA QSR CFR 21 Part 820.
What you will do
* Establishing, reviewing and updating quality management system documentation (inc. standard operating procedures – SOP’s) to ensure compliance with relevant international standards, regulatory requirements and industry guidelines.
* Customer complaints (core responsibility): QA lead for the management/handling of all customer complaints from initial intake through to closure in accordance with QMS requirements.
* Internal audit (core responsibility): Execution of internal audits across all areas of the business in-line with the audit plan to determine compliance with the relevant international standards (inc. ISO 13485:2016) & regulatory requirements.
* Non-conformance reporting - including the management of corrective and/or preventative actions (CAPA’s).
* The provision of QA support to the Blink QC Inspection team and the supplied quality of sub-contract manufactured instruments.
* Sterilisation final release (ethylene oxide & gamma irradiation) in accordance with QMS requirements.
* Provision of quality assurance support, as directed by the QA Director and in conjunction with other departments, in accordance with business needs to support the latest regulatory requirements.
What you will need (job requirements)
* Good Communications & IT skills (inclusive of Microsoft Office)
* Ability to manage workload and prioritize tasks according to business needs and relevant deadlines
* Good analytical & problem-solving skills (root cause analysis)
* A minimum degree level education, or 3-years’ experience within a quality assurance role, ideally within a medical device company
* Experience of working with ISO 13485:2016 certified QMS (essential)
* QMS Auditor Training (essential/preferrable – ISO 13485 / ISO 9001)
* Experience within a Quality Assurance role within a Medical Device company (essential/preferrable)
* Experience in the management of customer complaints and non-conformance reporting (essential/preferrable)
* Experience of working with regulatory requirements, such as UK MDR 2002 (SI 618); MDD 93/42/EEC; MDR 2017/745 & FDA QSR 21 CFR 820 (desirable)
* Experience of Microsoft D365 and/or Veeva Vault (desirable)
* Ability to provide support within other areas of the business as needed.
What we value
* Customer First: We deliver extraordinary experiences.
* Accountability: We do what we say.
* Integrity: We do what is right.
* Inspired: We love what we do.
* One Global Team: We before me, always.
Join us today and Excel@Corza!
Corza Medical is an equal opportunity employer. Corza Medical evaluates qualified applicants without regard to race, color, marital status, religion, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, veteran status or other protected characteristics.
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