Government, Regulatory and Code, Quality, Quality Engineering
Job Functions: (Primary “essential” duties and responsibilities)
Plans, organizes, and reports supplier performance to provide key information to the department manager and outside departments.
Strategically plan, develop, promote, and implement programs designed to improve supplier performance and productivity and reduce overall costs.
Participate in supplier selection process and perform supplier audits to evaluate supplier capabilities, quality systems, processes and services.
Perform validations and qualifications of supplier to qualify manufacturing processes and overall quality of part/component manufacturing.
Assists incoming quality and participates in MRB process to resolve internal and external quality audit findings related to purchased products.
Own and relentlessly drive supplier root cause analysis and corrective actions to prevent reoccurrence of quality issues.
Ensure primary suppliers have adequate control plans, schedules, and resources to make continued improvements to incoming quality of supplied products.
Works with Engineering and Quality to ensure that incoming product specifications contain and clearly communicate the requirements needed to ensure supplied products are acceptable for manufacturing and assist in the development of inspection methods and improve sampling plans for new materials and components.
Identifies non-conformance trends; develops and administers technical investigations and corrective action programs to resolve recurring quality problems.
Provide technical assistance to suppliers/other resources performing qualification/validation testing.
Provide statistical support by the creation of supplier related metrics for the purposes of tracking vendor performance and identifying opportunities for supply chain improvements.
Assists in special projects as needed.
Contributes to team effort by accomplishing related duties as requested.
Required Knowledge, Skills and Abilities:
Bachelor’s Degree preferred in Science or Engineering related fields and/or combination of school and experience.
Minimum five years direct experience in a supplier quality role in medical device, or 10+ years’ experience in a quality/engineering related field.
External audit experience required.
Excellent verbal and written communication skills with the ability to build trust and relationships with external people.
Very knowledgeable in the areas of lot acceptance sampling methodologies, MSA/GR&R, CAPA, root cause analysis, SPC and other statistical techniques.
Working knowledge to applicable regulations and standards such as FDA, QSR, ISO, and MDD preferred.
Strong PC skills, including MS Office (Excel/Word) and statistical software (preferably Minitab).
Getinge Group is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.
Getinge Group is a leading global provider of products and systems that contribute to quality enhancement and cost efficiency within healthcare and life sciences. The aim is to be the most desired medtech company in the world.Getinge's offering is mainly targeted at care providers, care givers and care receivers. The offering to hospitals is organized in three areas: Enable, Treat and Care. This a...llows Getinge to identify customer issues at an early stage, promote clinical and economic benefits and follow and support the customer decision process. Getinge's unique offering mirrors the hospital's organization and value chain, and the solutions are used before, during and after the patients' hospital stay.