The company is looking for a Product Quality Subject Matter Expert to embed and champion quality principles throughout the facility's daily operations, ensuring quality is upheld from product concept through obsolescence.
Requirements
- Proficient in all essential skills and experience required of the Product Quality Engineer role.
- Advanced computer competency in MS Office (e.g., Outlook, Word, Excel, Visio) and business specific software (e.g., ERP, eQMS), IQMS is preferred.
Responsibilities
- Interprets product related standards, customer and user needs to define robust, traceable design inputs and product requirements.
- Establishes design and development plans (DDP) for assigned projects, ensuring compliance with design control requirements; aligns with program milestones.
- Manages supplier controls, including qualification, audits, and ongoing performance monitoring and SCARs.
- Authors manufacturing risk documentation (PFMEA, control plans, process validations) to ensure efficient and effective design transfer to production.
- Ensures product labeling, IFUs, packaging, and safety documentation meet established requirements and supported by objective evidence, including appropriate use of symbols and UDI.
- Applies statistical methods (e.g., SPC, trend analysis, hypothesis testing) to monitor product and process performance, support investigations, and drive SCAR/CAPA effectiveness.
- Ensures mechanical and electrical specifications within the DMR reflect validated design outputs and incorporate risk mitigations and quality requirements.
Other
- Bachelor’s degree in engineering (electrical or mechanical) or related technical field or equivalent combination of training and experience.
- A minimum of 5-7 years of quality or regulatory experience is required. Experience in the medical device manufacturing industry is preferred.
- Proficient in understanding and interpretation of written and verbal instructions, directions, and technical information.
- Influencing people; inspires alignment and action by effectively persuading and motivating others to achieve outcomes.
- Making complex decisions; solving multifaceted problems with clarity and confidence.
